Multiple Myeloma Patient Registry

The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
  • Arkansas
    • Fort Smith, Arkansas, United States, 72903-4100
      • Mercy Research
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernard's Medical Center
    • Little Rock, Arkansas, United States, 72205
      • CARTI
  • California
    • Mission Hills, California, United States, 91345
      • Facey Medical Group
    • Oceanside, California, United States, 92056
      • North County Oncology
    • Oxnard, California, United States, 93030
      • Ventura County Hematology Oncology Specialists
    • West Hollywood, California, United States, 90069
      • James R. Berenson, MD Inc.
    • Whittier, California, United States, 90602
      • PIH Health Hospital
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • University Cancer Institute (UCI)
    • Fort Lauderdale, Florida, United States, 33308
      • Southeast Florida Hematology Oncology Group
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
    • Jacksonville, Florida, United States, 33256
      • Cancer Specialists of North Florida
    • Lakeland, Florida, United States, 33805
      • Watson Clinic LLP
    • Ocala, Florida, United States, 34471
      • Ocala Oncology Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Piedmont Cancer Institute
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Hospital System, Inc
    • Savannah, Georgia, United States, 31405
      • Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs Candler Health System
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital Cancer Research Center
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Baptist Healthcare Systems, Inc. d/b/a Baptist Health Floyd
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Physicians' Clinic of Iowa, P.C at PCI Main Building
  • Kentucky
    • Danville, Kentucky, United States, 40422
      • Commonwealth Hematology-Oncology, P.C.
    • Elizabethtown, Kentucky, United States, 42701
      • Hardin Memorial Hospital
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Care
    • Paducah, Kentucky, United States, 42003
      • Oncology Associates of West Kentucky
    • Paducah, Kentucky, United States, 42003
      • West Kentucky Hematology-Oncology
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Pontchartrain Cancer Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital & Clinics
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • Reliant Medical Group, Inc.
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Midland, Michigan, United States, 48640
      • MidMichigan Health Cancer Center
    • Southfield, Michigan, United States, 48075
      • Providence Cancer Center
  • Minnesota
    • Duluth, Minnesota, United States, 55802
      • St. Luke's Speciality Clinic
  • Mississippi
    • Pascagoula, Mississippi, United States, 39581
      • Singing River Health System
  • New Jersey
    • Elizabeth, New Jersey, United States, 07207
      • Trinitas Comprehensive Cancer Center
    • Williamstown, New Jersey, United States, 08360
      • Southern Oncology Hematology Associates
  • New York
    • East Setauket, New York, United States, 11733
      • North Shore Hematology Oncology Associates, P.C.
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Hematology Oncology Associates
    • Rochester, New York, United States, 14620
      • Community Health Network
  • Ohio
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
    • Kettering, Ohio, United States, 45409
      • Dayton Physicians, LLC
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Good Samaritan Hospital Corvallis
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • Lehigh Valley Health network (Oncology)
    • Dunmore, Pennsylvania, United States, 18512
      • Hematology and Oncology Associates of NEPA
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19114
      • Aria Health- Torresdale
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Wellmont Blue Ridge Medical Specialists
    • Jacksonville, Tennessee, United States, 38301
      • Jackson Madison County General Hospital
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Oncology P A
    • Beaumont, Texas, United States, 77702-1449
      • Texas Oncology P A
    • Denton, Texas, United States, 76210
      • Texas Oncology P A
    • Flower Mound, Texas, United States, 75028
      • Texas Oncology P.A.
    • Houston, Texas, United States, 77024
      • Texas Oncology-Memorial City
    • Paris, Texas, United States, 75460
      • Texas Oncology P.A.
    • Plano, Texas, United States, 75075
      • Texas Oncology P A
    • Tyler, Texas, United States, 75702
      • Texas Oncology P.A.
    • Waco, Texas, United States, 76712
      • Texas Oncology P A
    • Webster, Texas, United States, 77598
      • Texas Oncology P.A.
    • Wichita Falls, Texas, United States, 76310
      • Texas Oncology P.A.
  • Washington
    • Kennewick, Washington, United States, 99336
      • Kadlec Clinic Hematology & Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants to be enrolled in this registry will be participants whose multiple myeloma (MM) has relapsed after the administration of 1 to 3 prior lines of therapy and who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments within 90 days prior to study enrollment. Participants are to be recruited from medical centers in the United States.

Description

Inclusion Criteria:

• Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
• Have a diagnosis of relapsed MM [according to 2014 International Myeloma Working Group (IMWG) criteria] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
• Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 90 days prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
• Must be willing and able to complete the protocol-required patient-reported outcome (PROs)

Exclusion Criteria:

• Participant has plasma cell leukemia [greater than (>) 2.0 * 10^9 per liter] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
• Participant has a life expectancy of less than 6 months
• At the time of screening, participant is enrolled in an interventional clinical trial for MM using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Relapsed Multiple Myeloma Participants; The participants in the United States with a confirmed diagnosis of relapsed multiple myeloma following 1 to 3 prior lines of therapy who initiate treatment with a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments as per routine clinical practice within 90 days prior to study enrollment. These participants will be observed for the sequence of systemic myeloma treatments used during routine clinical practice, considering the life expectancy of patients with myeloma in the registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	Overall response rate defined as the percentage of participants achieving Complete Response (CR), Very good partial response (VGPR), or Partial response (PR) (CR + VGPR + PR) as per International Myeloma Working Group (IMWG 2016) criteria. CR as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and less than(<) 5 percent (%) plasma cells in bone marrow(BM). VGPR as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or greater than (>) reduction in serum and urine M-protein level <100 milligram (mg) per 24 hour (hr). PR as greater than or equal to (>=) 50% reduction of serum M-protein and less than (>=) 90% of urine M-protein or up to <200 mg per 24 hour.	Up to 3 years
Time to Next Treatment (TTNT)	TTNT is defined as the time from the date of initiation of regimen for induction to the initiation of next regimen for each successive therapy received.	Up to 3 years
Overall Survival (OS)	OS is defined as the time from the date of initiation of therapy to the date of death from any cause (or last documented follow-up).	Up to 3 years
Survival Time	Survival time is defined as the time from the start of each respective treatment to death (or last documented follow-up).	Up to 3 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score	EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants. It is composed of 30 items, multiitem measure (28 items) and 2 single-item measures. For the multiple item measure, 4 point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7 point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.	Up to 3 years
Katz Index of Independence for Activities of Daily Living	A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding. The index having values from A to G. A indicates independence in all six functions and G indicates dependence in all six Functions.	Up to 3 years
Lawton Instrumental Activities of Daily Living	This questionnaire measures participants' abilities to do instrumental activities of daily living such as ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibilities of own medication and managing finances. The scale ranges from 0 to 8, a lower scale indicates higher level of dependence.	Up to 3 years

Collaborators and Investigators

• Sponsor: Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): April 6, 2018
• Study Completion (Actual): April 6, 2018

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CR108326; NOPRODMMY4001 (Other Identifier: Janssen Scientific Affairs, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes