Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

October 24, 2023 updated by: SWOG Cancer Research Network

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of "Intermediate Fit" Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance

This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare progression-free survival (PFS) in frail or selected intermediate fit newly diagnosed multiple myeloma (NDMM) participants treated with bortezomib with lenalidomide and dexamethasone at reduced dosing (VRd-Lite) induction followed by lenalidomide maintenance (Arm 1) versus daratumumab and hyaluronidase-fihj with lenalidomide and dexamethasone (DRd) induction followed by lenalidomide maintenance (Arm 2).

II. To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase-fihj maintenance (Arm 3).

SECONDARY OBJECTIVES:

I. To compare PFS in Arm 1 versus Arm 3 II. To compare OS in Arm 1 versus Arm 2. III. To compare PFS in Arm 2 versus 3. IV. To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.

V. To compare the safety of Arm 1 with the safety of Arm 2 and Arm 3. VI. To explore veinous thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.

VII. To describe median time to response (complete response [CR] or better per International Myeloma Working Group [IMWG] criteria, very good partial response [VGPR] or better per IMWG criteria, partial response [PR] or better per IMWG criteria) on the three study arms.

PRIMARY QUALITY OF LIFE (QOL) OBJECTIVE:

I. To compare patient-reported global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) at 9 months after randomization (end of induction therapy) using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30).

SECONDARY QOL OBJECTIVE:

II. To compare longitudinal changes in global health status between treatment arms (Arm 1 versus the combination of Arms 2 and 3) from baseline to 9 months after randomization (end of induction therapy).

PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE:

I. To compare selected patient-reported outcome symptoms using PRO-CTCAE items among the 3 study arms.

ADDITIONAL OBJECTIVES:

I. To compare the rate of minimal residual disease (MRD) by clonoSEQ after 9 cycles of induction in Arm 1 versus Arm 2 and Arm 3, respectively.

II. To compare the rate of MRD conversion after 1 year of maintenance in participants who were MRD positive after induction in Arm 1 versus Arm 2 and Arm 3, respectively.

III. To compare the rate of sustained MRD negativity at time points of post-induction, post-1 year maintenance in Arm 1 versus Arm 2 and Arm 3, respectively.

BANKING OBJECTIVES:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I (VRd-Lite):

INDUCTION CYCLES 1-9: Patients receive bortezomib subcutaneously (SC) on days 1, 8, 15, and 22 of each cycle, lenalidomide orally (PO) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II (DRd-R):

INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III (DRd-DR):

INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99504
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 501-686-8274
        • Principal Investigator:
          • Samer Al Hadidi
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • John L McClellan Memorial Veterans Hospital
        • Principal Investigator:
          • Rangaswamy Govindarajan
        • Contact:
    • California
      • Arroyo Grande, California, United States, 93420
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy Cancer Center �� Carmichael
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy San Juan Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Elk Grove, California, United States, 95758
        • Recruiting
        • Mercy Cancer Center - Elk Grove
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Principal Investigator:
          • Aaron Rosenberg
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Rocklin, California, United States, 95765
        • Recruiting
        • Mercy Cancer Center - Rocklin
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Principal Investigator:
          • Aaron Rosenberg
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
      • Sacramento, California, United States, 95816
        • Recruiting
        • Mercy Cancer Center - Sacramento
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • San Luis Obispo, California, United States, 93401
      • Santa Maria, California, United States, 93444
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • Providence Santa Rosa Memorial Hospital
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Truckee, California, United States, 96161
        • Recruiting
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
        • Principal Investigator:
          • Aaron Rosenberg
        • Contact:
          • Site Public Contact
          • Phone Number: 530-582-6450
      • Woodland, California, United States, 95695
        • Recruiting
        • Woodland Memorial Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose-Saint Francis Healthcare
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Rocky Mountain Cancer Centers-Penrose
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Saint Francis Cancer Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Porter Adventist Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Durango, Colorado, United States, 81301
        • Recruiting
        • Mercy Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Durango, Colorado, United States, 81301
        • Recruiting
        • Southwest Oncology PC
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Saint Anthony Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Littleton Adventist Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Longmont, Colorado, United States, 80501
        • Recruiting
        • Longmont United Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Parker, Colorado, United States, 80138
        • Recruiting
        • Parker Adventist Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Pueblo, Colorado, United States, 81004
        • Recruiting
        • Saint Mary Corwin Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Recruiting
        • Smilow Cancer Hospital-Derby Care Center
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Smilow Cancer Hospital Care Center-Fairfield
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Glastonbury, Connecticut, United States, 06033
        • Recruiting
        • Smilow Cancer Hospital Care Center at Glastonbury
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Smilow Cancer Hospital Care Center at Greenwich
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guilford
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Smilow Cancer Center/Yale-New Haven Hospital
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • North Haven, Connecticut, United States, 06473
        • Recruiting
        • Yale-New Haven Hospital North Haven Medical Center
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Torrington, Connecticut, United States, 06790
        • Recruiting
        • Smilow Cancer Hospital-Torrington Care Center
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Smilow Cancer Hospital-Waterbury Care Center
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Sikander Ailawadhi
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 561-745-5768
        • Principal Investigator:
          • Ryan H. Devine
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • Saint Anthony's Health
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Bloomington, Illinois, United States, 61701
        • Recruiting
        • Saint Joseph Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Burr Ridge, Illinois, United States, 60527
        • Recruiting
        • Loyola Center for Health at Burr Ridge
        • Principal Investigator:
          • Patrick A. Hagen
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Saint Mary's Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Western Illinois Cancer Treatment Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 309-344-2831
      • Homer Glen, Illinois, United States, 60491
        • Recruiting
        • Loyola Medicine Homer Glen
        • Principal Investigator:
          • Patrick A. Hagen
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Patrick A. Hagen
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
      • Melrose Park, Illinois, United States, 60160
        • Recruiting
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
        • Principal Investigator:
          • Patrick A. Hagen
        • Contact:
          • Site Public Contact
          • Phone Number: 708-450-4554
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • The Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
    • Iowa
      • Cedar Rapids, Iowa, United States, 52402
        • Recruiting
        • Physicians' Clinic of Iowa PC
        • Contact:
          • Site Public Contact
          • Phone Number: 319-297-2900
        • Principal Investigator:
          • William P. Fusselman
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Medical Oncology and Hematology Associates-West Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Council Bluffs, Iowa, United States, 51503
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mission Cancer and Blood - Laurel
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Corbin, Kentucky, United States, 40701
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • Saint Joseph Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • London, Kentucky, United States, 40741
      • Mount Sterling, Kentucky, United States, 40353
        • Recruiting
        • Saint Joseph Mount Sterling
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Caro, Michigan, United States, 48723
        • Recruiting
        • Caro Cancer Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Clarkston, Michigan, United States, 48346
      • Clarkston, Michigan, United States, 48346
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Great Lakes Cancer Management Specialists-Doctors Park
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Cancer and Blood Disease Treatment Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Academic Hematology Oncology Specialists
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 517-364-9400
        • Principal Investigator:
          • Elie G. Dib
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Marlette, Michigan, United States, 48453
        • Recruiting
        • Saint Mary's Oncology/Hematology Associates of Marlette
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • 21st Century Oncology-Pontiac
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Saginaw, Michigan, United States, 48604
        • Recruiting
        • Oncology Hematology Associates of Saginaw Valley PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Sterling Heights, Michigan, United States, 48312
        • Recruiting
        • Bhadresh Nayak MD PC-Sterling Heights
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Tawas City, Michigan, United States, 48764
        • Recruiting
        • Ascension Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48088
        • Recruiting
        • Advanced Breast Care Center PLLC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Macomb Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Michigan Breast Specialists-Warren
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Saint John Macomb-Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • West Branch, Michigan, United States, 48661
        • Recruiting
        • Saint Mary's Oncology/Hematology Associates of West Branch
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Sikander Ailawadhi
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Thief River Falls, Minnesota, United States, 56701
        • Recruiting
        • Sanford Thief River Falls Medical Center
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
      • Worthington, Minnesota, United States, 56187
        • Recruiting
        • Sanford Cancer Center Worthington
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Southeast Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-651-5550
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Capital Region Southwest Campus
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63109
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • Missouri Baptist Outpatient Center-Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Nebraska
      • Kearney, Nebraska, United States, 68847
      • Lincoln, Nebraska, United States, 68510
      • Omaha, Nebraska, United States, 68122
      • Omaha, Nebraska, United States, 68124
      • Omaha, Nebraska, United States, 68130
      • Omaha, Nebraska, United States, 68131
      • Papillion, Nebraska, United States, 68046
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Shashank Cingam
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Sanford South University Medical Center
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 701-234-6161
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Southpointe-Sanford Medical Center Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Sanford Medical Center Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 800-437-4010
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45247
      • Cincinnati, Ohio, United States, 45255
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
      • Oklahoma City, Oklahoma, United States, 73104
        • Not yet recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Manu Pandey
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
        • Principal Investigator:
          • Charles W. Drescher
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Lehigh Valley Hospital-Hazleton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • Rhode Island
      • Westerly, Rhode Island, United States, 02891
        • Recruiting
        • Smilow Cancer Hospital Care Center - Westerly
        • Contact:
        • Principal Investigator:
          • Elan Gorshein
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Easley, South Carolina, United States, 29640
        • Recruiting
        • Prisma Health Cancer Institute - Easley
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Avera Cancer Institute-Aberdeen
        • Contact:
        • Principal Investigator:
          • Xavier Andrade-Gonzalez
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
        • Principal Investigator:
          • Xavier Andrade-Gonzalez
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • Avera Cancer Institute at Yankton
        • Contact:
        • Principal Investigator:
          • Xavier Andrade-Gonzalez
    • Virginia
      • Martinsville, Virginia, United States, 24115
        • Recruiting
        • Sovah Health Martinsville
        • Principal Investigator:
          • Ana M. Ventura
        • Contact:
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 360-788-8223
        • Principal Investigator:
          • Charles W. Drescher
      • Bremerton, Washington, United States, 98310
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Shelton, Washington, United States, 98584
        • Recruiting
        • Providence Regional Cancer System-Shelton
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Yelm, Washington, United States, 98597
        • Recruiting
        • Providence Regional Cancer System-Yelm
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Yazhini Vallatharasu
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • David E. Marinier
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration

  • Participants must have measurable disease within 28 days prior to registration as defined by any of the following:

    • Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR
    • IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR
    • Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
  • All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
  • Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration

  • For Participants Meeting "Frail" Status:

    • Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible

  • For Participants Meeting "Frail" Status:

    • Hemoglobin >= 7 g/dL (must be performed within 28 days prior to registration)

      • Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)

  • For Participants Meeting "Frail" Status:

    • Platelets >= 50 x 10^9/L (must be performed within 28 days prior to registration)

      • Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)

  • For Participants Meeting "Frail" Status:

    • Absolute neutrophil count (ANC) >= 0.75 x10^9/L (must be performed within 28 days prior to registration)

      • Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)

  • For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present:

    • Kidney dysfunction showing calculated creatinine clearance (CrCl) <30 ml/min.

      • Actual lab serum creatinine value with a minimum of 0.7 mg/dL.

    • Participants must have bone marrow function assessed and meet the below criteria ranges:

      • Hemoglobin between 7-8 g/dL, OR
      • Platelets between 50-75 x10^9/L, OR

      • ANC between 0.75-1 x10^9/L

        • Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)
    • Revised International Staging System (R-ISS) stage III disease
    • Note: All labs must be performed within 28 days prior to registration
  • Participants must have a complete medical history and physical exam within 28 days prior to registration
  • Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form.
  • Total bilirubin =< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 × institutional ULN (within 28 days prior to registration)
  • Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4
  • Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C > 7
  • Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration
  • All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration
  • Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score [PS] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed)
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
  • Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Exclusion Criteria:

  • Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:

    • An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
    • Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or
    • Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
  • Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
  • Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =< 140 and DBP =< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (VRd-Lite)

INDUCTION CYCLES 1-9: Patients receive bortezomib SC on days 1, 8, 15, and 22 of each cycle, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
Drug: Dexamethasone
Given PO
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Drug: Bortezomib
Given SC
Other Names:
  • Velcade
  • MLN341
  • PS-341
  • LDP 341
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • PS341
Experimental: Arm II (DRd-R)

INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE CYCLES 10+: Patients receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
Drug: Dexamethasone
Given PO
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Drug: Daratumumab and Hyaluronidase-fihj
Given SC
Other Names:
  • DARA Co-formulated with rHuPH20
  • DARA/rHuPH20
  • Daratumumab + rHuPH20
  • Daratumumab with rHuPH20
  • Daratumumab-rHuPH20
  • Daratumumab/Hyaluronidase-fihj
  • Daratumumab/rHuPH20 Co-formulation
  • Darzalex Faspro
  • Darzalex/rHuPH20
  • HuMax-CD38-rHuPH20
  • Recombinant Human Hyaluronidase Mixed with Daratumumab
Experimental: Arm III (DRd-DR):

INDUCTION CYCLES 1-9: Patients receive daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide PO on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE CYCLES 10+: Patients receive daratumumab and hyaluronidase-fihj SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
Drug: Dexamethasone
Given PO
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Drug: Daratumumab and Hyaluronidase-fihj
Given SC
Other Names:
  • DARA Co-formulated with rHuPH20
  • DARA/rHuPH20
  • Daratumumab + rHuPH20
  • Daratumumab with rHuPH20
  • Daratumumab-rHuPH20
  • Daratumumab/Hyaluronidase-fihj
  • Daratumumab/rHuPH20 Co-formulation
  • Darzalex Faspro
  • Darzalex/rHuPH20
  • HuMax-CD38-rHuPH20
  • Recombinant Human Hyaluronidase Mixed with Daratumumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2
Time Frame: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by fluorescence in situ hybridization (iFISH) (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
Overall survival (OS) of Arm 1 vs. Arm 3
Time Frame: From date of randomization to date of death due to any cause, or assessed up to 10 years
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by iFISH (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
From date of randomization to date of death due to any cause, or assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
Analysis of PFS and OS endpoints will be performed using a stratified log-rank test for comparison between arms, with stratification according to frailty score (frail vs. intermediate fit) presence of one or more high-risk abnormalities by iFISH (yes vs. no) and prior therapy (yes vs. no).
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
OS
Time Frame: From date of randomization to date of death due to any cause, or assessed up to 10 years
Analysis of PFS and OS endpoints will be performed using a stratified log-rank test for comparison between arms, with stratification according to frailty score (frail vs. intermediate fit) presence of one or more high-risk abnormalities by iFISH (yes vs. no) and prior therapy (yes vs. no).
From date of randomization to date of death due to any cause, or assessed up to 10 years
Overall response rate (ORR)
Time Frame: Up to 10 years
ORR is defined as the percentage of participants achieving a best response of partial response (PR) or better while on study. ORR will be reported with a binomial confidence interval. Time to response will be analyzed using the cumulative incidence competing risks method.
Up to 10 years
Time to complete response (CR)
Time Frame: The time from the date of registration to the date of the first documented incidence of a response of CR or better, assessed up to 10 years
All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method.
The time from the date of registration to the date of the first documented incidence of a response of CR or better, assessed up to 10 years
Time to very good partial response (VGFR)
Time Frame: The time from the date of registration to the date of the first documented incidence of a response of VGPR or better, assessed up to 10 years
All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method.
The time from the date of registration to the date of the first documented incidence of a response of VGPR or better, assessed up to 10 years
Time to PR
Time Frame: The time from the date of registration to the date of the first documented incidence of a response of PR or better, assessed up to 10 years
All eligible participants will be considered in analyses of the secondary endpoints, according to their assigned arm at randomization, and with participants who go off-study prior to response assessment considered as non-responders for the analysis of response rate and as censored at the time of removal from study for the analysis of time to response. Time to response will be analyzed using the cumulative incidence competing risks method.
The time from the date of registration to the date of the first documented incidence of a response of PR or better, assessed up to 10 years
Minimal residual disease (MRD)
Time Frame: At 9 months of induction therapy and 1 year of maintenance therapy
The rate of MRD negativity will be calculated at each timepoint as the number of patients who are MRD negative divided by the number of patients who were eligible, analyzable and assessable for clinical response assessment at that timepoint. Rates of MRD negativity will be compared using a two-arm binomial test.
At 9 months of induction therapy and 1 year of maintenance therapy
Patient report out comes (PRO) quality-of-life (QOL)
Time Frame: At baseline and months 1, 3, 9, and 18 after randomization
We will use the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (version 3). This instrument includes questions broadly applicable to all cancer patients, assessing 5 functional domains (physical, role, cognitive, emotional, social) and 8 symptoms (fatigue, pain, nausea/vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea), together with financial problems and global quality of life.
At baseline and months 1, 3, 9, and 18 after randomization
Patient-reported toxicity (PRO-Common Terminology Criteria for Adverse Events [CTCAE])
Time Frame: At baseline, at each treatment cycle up to month 18 from randomization, and at discontinuation of treatment
PRO-CTCAE is intended to enhance the quality of adverse event data reporting in clinical trials, provide data that complements and extends the information provided by clinician reporting using CTCAE, represent the patient perspective of the experience of symptomatic adverse events (AEs), and improve detection of potentially serious adverse events. Descriptive statistics will be used to summarize selected PRO-CTCAEs tabulated at each cycle overall and by arm. We will examine the extent to which PRO-CTCAEs with provider reported AEs are correlated and evaluate differences in incidence and worst severity.
At baseline, at each treatment cycle up to month 18 from randomization, and at discontinuation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sikander Ailawadhi, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2023

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

April 15, 2030

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2209 (Other Identifier: CTEP)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • NCI-2022-05722 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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