Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant

January 5, 2015 updated by: National Cancer Institute (NCI)

A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant

This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, liposomal doxorubicin, dexamethasone, and cyclophosphamide.

SECONDARY OBJECTIVES:

I. To evaluate response rates in patients treated with this regimen.

II. To evaluate the median time to progression in patients treated with this regimen.

III. To evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples may be collected for future research. Patients complete the Functional Assessment of Cancer Therapy (FACT) neurotoxicity questionnaire periodically.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • Colorado Cancer Research Program CCOP
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Grand Junction, Colorado, United States, 81502
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Georgia
      • Macon, Georgia, United States, 31208
        • Medical Center of Central Georgia
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital Association
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare Galesburg
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, United States, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Ottawa, Illinois, United States, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, United States, 61554
        • Pekin Cancer Treatment Center
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Oncology Research Association CCOP
      • Peru, Illinois, United States, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
    • Iowa
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Des Moines, Iowa, United States, 50309
        • Iowa Oncology Research Association CCOP
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology Oncology Associates
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67901
        • Cancer Center of Kansas-Liberal
      • McPherson, Kansas, United States, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67214
        • Wichita CCOP
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Maryland
      • Elkton MD, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Eastern Cooperative Oncology Group
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro-Minnesota CCOP
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Cincinnati, Ohio, United States, 45236
        • The Jewish Hospital
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care-Clyde
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center Incorporated
      • Elyria, Ohio, United States, 44035
        • Community Health Partners Regional Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Norwalk, Ohio, United States, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital/Toledo Children's Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Saint Anne Hospital
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
    • Pennsylvania
      • Butler, Pennsylvania, United States, 16001
        • Butler Memorial Hospital
      • Danville, Pennsylvania, United States, 17822-2001
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazelton
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
    • Wisconsin
      • Johnson Creek, Wisconsin, United States, 53038
        • UW Cancer Center Johnson Creek
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of multiple myeloma that was symptomatic at the time of initial diagnosis

  • Must have met the following criteria at one point during the disease course:

    • Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma

    • Symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, including at least 1 of the following:

      • Anemia
      • Hypercalcemia
      • Bone disease (lytic bone lesions or pathologic fracture)
      • Renal dysfunction
  • Disease relapsed < 12 months after autologous stem cell transplantation (SCT)

  • Measurable disease, as defined by the presence of ≥ 1 of the following:

    • Serum M-spike ≥ 1 g/dL
    • Urine M-spike ≥ 200 mg/24 hours
    • Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal)
    • Plasma cells ≥ 30%
  • ECOG performance status 0-2
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • At least 14 days since prior palliative and/or localized radiotherapy
  • Left ventricular ejection fraction (LVEF) normal by Echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan
  • Hemoglobin > 8 g/dL
  • Platelet count ≥ 75,000/mm^3 (without transfusion support)
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (without use of growth factors)
  • Creatinine < 2.5 mg/dL
  • Direct bilirubin ≤ 1.5 mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal

  • All tests below must be performed within 14 days prior to registration:

    • Serum free light chain assay
    • Kappa free light chain
    • Lambda free light chain

  • Prior malignancy allowed provided it was treated curatively and has not relapsed in 5 years

    • Patients with basal cell skin cancer, in situ cervical cancer, or prostate cancer not requiring therapy are eligible

Exclusion Criteria:

  • Therapy for relapsed disease following SCT
  • Known allergy to bortezomib or anthracyclines
  • Prior allogeneic SCT
  • Peripheral neuropathy ≥ grade 2 according to the Cancer Therapy Evaluation Program (CTEP) active version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)

  • Concurrent uncontrolled illness that would limit study compliance, including the following:

    • Uncontrolled hypertension
    • Symptomatic congestive heart failure
    • Unstable angina
    • Uncontrolled cardiac arrhythmia
    • Uncontrolled psychiatric illness or social situation
    • Active uncontrolled infection
  • Prior doxorubicin hydrochloride exposure > 240 mg/m^2
  • Active, uncontrolled seizure disorder
  • Seizures within the past 6 months
  • Pregnant or nursing

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (combination chemotherapy)
Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Drug: dexamethasone
Given orally
Other Names:
  • Decadron
  • DXM
  • Dexameth
  • Dexone
  • Hexadrol
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • Neosar
Drug: liposomal doxorubicin
Given IV
Other Names:
  • Doxil
  • Doxorubicin HCl Liposomal
  • Doxorubicin Hydrochloride Liposome
  • Doxorubicin Hydrochloride Liposomal
Drug: bortezomib
Given subcutaneously.
Other Names:
  • Velcade
  • PS-341
  • LDP-341
  • MLN-341

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year Survival in Patients Treated With This Regimen.
Time Frame: Assessed at 1 year
Proportion of patients who are still alive at 1 year after registration.
Assessed at 1 year

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Shaji Kumar, M.D., Mayo Clinic

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

September 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 27, 2010

First Submitted That Met QC Criteria

February 27, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2011-02002 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA021115 (U.S. NIH Grant/Contract)
  • E2A08 (Other Identifier: Eastern Cooperative Oncology Group (ECOG))

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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