Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
2 other identifiers
interventional
273
1 country
42
Brief Summary
This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents will improve long-term progression-free survival (PFS) after high-dose melphalan followed by autologous hematopoietic cell transplantation (HCT) as compared to a second autologous transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Mar 2015
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2019
CompletedResults Posted
Study results publicly available
May 11, 2020
CompletedMay 11, 2020
September 1, 2019
4.3 years
December 17, 2014
April 27, 2020
April 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Progression-free Survival (PFS)
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). 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, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period.
5 years post-randomization in BMT CTN 0702
Secondary Outcomes (4)
Percentage of Participants With Overall Survival (OS)
5 years post-randomization in BMT CTN 0702
Percentage of Participants With Event-free Survival (EFS)
5 years post-randomization in BMT CTN 0702
Percentage of Participants With Secondary Primary Malignancies (SPM)
5 years post-randomization in BMT CTN 0702
Percentage of Participants With Disease Progression
5 years post-randomization in BMT CTN 0702
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
In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
Eligibility Criteria
You may qualify if:
- Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:
- Enrolled and randomized on the BMT CTN 0702 protocol.
- Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
- Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
- Signed Informed Consent Form.
- Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
- Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:
- Enrolled and randomized to BMT CTN 0702.
- Completion of 3 years of maintenance therapy on BMT CTN 0702.
- Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
- Signed informed consent form.
- Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
You may not qualify if:
- Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:
- Patients who have evidence of disease progression prior to enrollment.
- Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
- Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) 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.
- Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
- Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
- Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)lead
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
Study Sites (42)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
University of California, San Diego Medical Center
La Jolla, California, 92093, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
University of Miami
Miami, Florida, 33624, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
BMT Group of Georgia (Northside Hospital)
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130, United States
DFCI, Brigham and Womens 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 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/Case Western
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
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
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 Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal, PhD
- Organization
- The Emmes Company
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2014
First Posted
December 23, 2014
Study Start
March 1, 2015
Primary Completion
June 7, 2019
Study Completion
June 7, 2019
Last Updated
May 11, 2020
Results First Posted
May 11, 2020
Record last verified: 2019-09
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).