Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT02322320
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 273
Starts: 2015-03-01
Expected to finish: 2019-06-07
Last updated by the study team: 2020-05-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
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.

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.

Where it is running

Arizona Cancer Center — Tucson, Arizona, United States
City of Hope National Medical Center — Duarte, California, United States
University of California, San Diego Medical Center — La Jolla, California, United States
Stanford Hospital and Clinics — Stanford, California, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
University of Florida College of Medicine — Gainesville, Florida, United States
University of Miami — Miami, Florida, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
BMT Group of Georgia (Northside Hospital) — Atlanta, Georgia, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Kansas Hospital — Kansas City, Kansas, United States
Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
DFCI, Brigham and Womens Hospital — Boston, Massachusetts, United States
University of Michigan Medical Center — Ann Arbor, Michigan, United States
Karmanos Cancer Institute/BMT — Detroit, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Washington University, Barnes Jewish Hospital — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Roswell Park Cancer Center — Buffalo, New York, United States
North Shore University Hospital — Lake Success, New York, United States
Mount Sinai Medical Center — New York, New York, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
University of North Carolina Hospital at Chapel Hill — Chapel Hill, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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