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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02322320
Other study ID # BMTCTN07LT
Secondary ID U01HL069294-05
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2015
Est. completion date June 7, 2019

Study information

Verified date September 2019
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004). All patients who consent will be followed for death, progression, Second Primary Malignancies (SPMs), and Quality of Life (QOL). Patients who do not consent to the long-term follow-up mechanism or who have experienced progression on the BMT CTN 0702 study will be followed through the standard Center for International Blood and Marrow Transplant Research (CIBMTR) long-term follow-up mechanism. Additionally, patients who are eligible and are willing to continue with lenalidomide as maintenance therapy will be provided lenalidomide free of charge. These patients will continue to receive lenalidomide as maintenance therapy until disease progression or discontinuation due to toxicity, death, or withdrawal from the study. The endpoints assessed will include progression-free survival (PFS), overall survival (OS), event-free survival (EFS), incidence of second primary malignancies (SPM) and health quality of life (QOL).


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date June 7, 2019
Est. primary completion date June 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:

1. Enrolled and randomized on the BMT CTN 0702 protocol.

2. Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.

3. Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.

4. Signed Informed Consent Form.

5. 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:

1. Enrolled and randomized to BMT CTN 0702.

2. Completion of 3 years of maintenance therapy on BMT CTN 0702.

3. 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.

4. Signed informed consent form.

5. 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:

1. Patients who have evidence of disease progression prior to enrollment.

2. 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.

3. Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.

4. 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.

5. Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.

6. Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.

7. Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenalidomide
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.

Locations

Country Name City State
United States University of Michigan Medical Center Ann Arbor Michigan
United States BMT Group of Georgia (Northside Hospital) Atlanta Georgia
United States DFCI, Brigham and Womens Hospital Boston Massachusetts
United States Roswell Park Cancer Center Buffalo New York
United States University of North Carolina Hospital at Chapel Hill Chapel Hill North Carolina
United States Rush University Medical Center Chicago Illinois
United States Jewish Hospital BMT Program Cincinnati Ohio
United States University Hospitals of Cleveland/Case Western Cleveland Ohio
United States Ohio State/Arthur G. James Cancer Hospital Columbus Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Colorado Blood Cancer Institute Denver Colorado
United States Karmanos Cancer Institute/BMT Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States University of Florida College of Medicine Gainesville Florida
United States Hackensack University Medical Center Hackensack New Jersey
United States Penn State College of Medicine, The Milton S. Hershey Medical Center Hershey Pennsylvania
United States University of Texas/MD Anderson CRC Houston Texas
United States University of Kansas Hospital Kansas City Kansas
United States University of California, San Diego Medical Center La Jolla California
United States North Shore University Hospital Lake Success New York
United States University of Wisconsin Hospital & Clinics Madison Wisconsin
United States University of Miami Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States West Virginia University Hospital Morgantown West Virginia
United States Sarah Cannon Blood & Marrow Transplant Program Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center New York New York
United States University of Oklahoma Medical Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Washington University, Barnes Jewish Hospital Saint Louis Missouri
United States Texas Transplant Institute San Antonio Texas
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Louisiana State University Health Sciences Center Shreveport Louisiana
United States Stanford Hospital and Clinics Stanford California
United States H. Lee Moffitt Cancer Center Tampa Florida
United States Arizona Cancer Center Tucson Arizona
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (4)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI) Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants With Overall Survival (OS) 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. 5 years post-randomization in BMT CTN 0702
Secondary Percentage of Participants With Event-free Survival (EFS) 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. 5 years post-randomization in BMT CTN 0702
Secondary Percentage of Participants With Secondary Primary Malignancies (SPM) 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
Secondary Percentage of Participants With Disease Progression 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:
Reappearance of serum monoclonal paraprotein at a level >= 0.5 g/dL
24-hour urine protein electrophoresis of at least 200mg paraprotein/24 hours
Abnormal free light chain levels of >10 mg/dl, only in patients without measurable paraprotein in serum and urine
At least 10% plasma cells in a bone marrow aspirate or trephine biopsy
Definite increase in the size of existing bone lesions or soft tissue plasmacytomas
Development of new bone lesions or soft tissue plasmacytomas
Development of hypercalcemia (corrected serum Ca >11.5 mg/dL or >2.8 mmol/L) not attributable to other causes
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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