- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322320
Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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California
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Duarte, California, United States, 91010-3000
- City of Hope National Medical Center
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La Jolla, California, United States, 92093
- University of California, San Diego Medical Center
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Stanford, California, United States, 94305
- Stanford Hospital and Clinics
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Colorado
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Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida College of Medicine
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Miami, Florida, United States, 33624
- University of Miami
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Tampa, Florida, United States, 33624
- H. Lee Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30342
- BMT Group of Georgia (Northside Hospital)
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Hospital
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Louisiana
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Shreveport, Louisiana, United States, 71130
- Louisiana State University Health Sciences Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- DFCI, Brigham and Womens Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48105-2967
- University of Michigan Medical Center
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute/BMT
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University, Barnes Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- University of Nebraska Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Center
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Lake Success, New York, United States, 11042
- North Shore University Hospital
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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New York, New York, United States, 10174
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7305
- University of North Carolina Hospital at Chapel Hill
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, United States, 45236
- Jewish Hospital BMT Program
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Cleveland, Ohio, United States, 44106-5061
- University Hospitals of Cleveland/Case Western
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Columbus, Ohio, United States, 43210
- Ohio State/Arthur G. James Cancer Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Medical Center
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health & Science University
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, The Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Blood & Marrow Transplant Program
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Nashville, Tennessee, United States, 37232-8210
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Houston, Texas, United States, 77030
- University of Texas/MD Anderson CRC
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San Antonio, Texas, United States, 78229
- Texas Transplant Institute
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Washington
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792-5156
- University of Wisconsin Hospital & Clinics
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Milwaukee, Wisconsin, United States, 53211
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Tandem Auto Transplant
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
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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.
Other Names:
|
Active Comparator: RVD Consolidation
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
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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.
Other Names:
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Active Comparator: Lenalidomide Maintenance
Initial autologous transplant followed by lenalidomide maintenance
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Progression-free Survival (PFS)
Time Frame: 5 years post-randomization in BMT CTN 0702
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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.
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5 years post-randomization in BMT CTN 0702
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Overall Survival (OS)
Time Frame: 5 years post-randomization in BMT CTN 0702
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This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause.
To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period.
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5 years post-randomization in BMT CTN 0702
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Percentage of Participants With Event-free Survival (EFS)
Time Frame: 5 years post-randomization in BMT CTN 0702
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This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Event-free survival is defined as survival without disease progression, second primary malignancy, and death.
To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate event-free survival during the 5 year post-randomization follow-up period.
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5 years post-randomization in BMT CTN 0702
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Percentage of Participants With Secondary Primary Malignancies (SPM)
Time Frame: 5 years post-randomization in BMT CTN 0702
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This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms. |
5 years post-randomization in BMT CTN 0702
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Percentage of Participants With Disease Progression
Time Frame: 5 years post-randomization in BMT CTN 0702
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This analysis includes all randomized subjects from BMT CTN 0702, classified by their treatment assignment (intention-to-treat). Disease progression is defined as progression of multiple myeloma, including one or more of the following:
To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of progression during the follow-up period. |
5 years post-randomization in BMT CTN 0702
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- Neoplasms, Plasma Cell
- Multiple Myeloma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- BMTCTN07LT
- U01HL069294-05 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
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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