Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant With Lenalidomide Maintenance for Patients With Multiple Myeloma (BMT CTN 0702)
4 other identifiers
interventional
758
1 country
54
Brief Summary
The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started May 2010
Typical duration for phase_3 multiple-myeloma
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2018
CompletedResults Posted
Study results publicly available
June 11, 2018
CompletedDecember 9, 2021
December 1, 2021
6.7 years
April 21, 2010
April 5, 2018
December 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Progression-free Survival (PFS)
Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.
38 months post-randomization
Secondary Outcomes (9)
Percentage of Participants With Disease Progression
38 months post-randomization
Percentage of Participants With Overall Survival (OS)
38 months post-randomization
Percentage of Participants With Treatment-related Mortality (TRM)
Up to 38 months post-randomization
Number of Participants With Treatment Response
1 and 2 years post-randomization
FACT-G Total Score
Up to 3 years post-randomization
- +4 more secondary outcomes
Study Arms (3)
Tandem auto transplant
ACTIVE COMPARATORInitial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
RVD consolidation
ACTIVE COMPARATORInitial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
Lenalidomide maintenance
ACTIVE COMPARATORInitial autologous transplant followed by lenalidomide maintenance
Interventions
All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
Eligibility Criteria
You may qualify if:
- Patients meeting the criteria for symptomatic multiple myeloma (MM).
- Patients who are 70 years of age, or younger, at time of enrollment.
- Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy.
- Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
- Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
- Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
- Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin).
- Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10\^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10\^6 CD34+ cells/kg patient weight.
- Signed informed consent form.
You may not qualify if:
- Patients who never fulfill the criteria for symptomatic MM.
- Patients with purely non-secretory MM \[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
- Patients with plasma cell leukemia.
- Karnofsky performance score less than 70 percent.
- Patients with greater than grade 2 sensory neuropathy (CTCAE).
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- Patients seropositive for the human immunodeficiency virus (HIV).
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Patient has received other investigational drugs with 14 days before enrollment.
- Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed.
- Female patients who are pregnant (positive B-HCG) or breastfeeding.
- Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
- Prior allograft or prior autograft.
- Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
UCSD Medical Center
La Jolla, California, 92093, United States
University of California, San Francisco
San Francisco, California, 94143-0324, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Christiana Care Health System
Newark, Delaware, 19718, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Blood and Marrow Transplant Program at Northside Hospital
Atlanta, Georgia, 30342, United States
Georgia Health Sciences University
Augusta, Georgia, 30912, United States
St. Lukes Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Wichita CCOP
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130, United States
DFCI, Brigham and Womens Hospital
Boston, Massachusetts, 02114, United States
DFCI, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48105-2967, United States
Karmanos Cancer Institute/BMT
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University, Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Center
Buffalo, New York, 14263, United States
North Shore University Hospital
Lake Success, New York, 11042, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10174, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599-7305, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Jewish Hospital BMT Program
Cincinnati, Ohio, 45236, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5061, United States
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, 43210, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
Penn State College of Medicine, The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Sarah Cannon Blood & Marrow Transplant Program
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8210, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine/The Methodist Hospital
Houston, Texas, 77030, United States
University of Texas, MD Anderson CRC
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-5156, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211, United States
Related Publications (2)
Stadtmauer EA, Pasquini MC, Blackwell B, Hari P, Bashey A, Devine S, Efebera Y, Ganguly S, Gasparetto C, Geller N, Horowitz MM, Koreth J, Knust K, Landau H, Brunstein C, McCarthy P, Nelson C, Qazilbash MH, Shah N, Vesole DH, Vij R, Vogl DT, Giralt S, Somlo G, Krishnan A. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial. J Clin Oncol. 2019 Mar 1;37(7):589-597. doi: 10.1200/JCO.18.00685. Epub 2019 Jan 17.
PMID: 30653422RESULTPasquini MC, Wallace PK, Logan B, Kaur M, Tario JD, Howard A, Zhang Y, Brunstein C, Efebera Y, Geller N, Giralt S, Hari P, Horowitz MM, Koreth J, Krishnan A, Landau H, Somlo G, Shah N, Stadtmauer E, Vogl DT, Vesole DH, McCarthy PL, Hahn T. Minimal Residual Disease Status in Multiple Myeloma 1 Year After Autologous Hematopoietic Cell Transplantation and Lenalidomide Maintenance Are Associated With Long-Term Overall Survival. J Clin Oncol. 2024 Aug 10;42(23):2757-2768. doi: 10.1200/JCO.23.00934. Epub 2024 May 3.
PMID: 38701390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal, PhD
- Organization
- The Emmes Corporation
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2010
First Posted
April 22, 2010
Study Start
May 1, 2010
Primary Completion
January 15, 2017
Study Completion
March 3, 2018
Last Updated
December 9, 2021
Results First Posted
June 11, 2018
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Within 6 months of official study closure at participating sites.
- Access Criteria
- Available to the public
Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).