Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Intervention: Lenalidomide
Intervention description: 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.
Intervention MeSH terms: Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Lenalidomide; Maintenance Therapy; Progression; Long-term; Anti-Myeloma Agents; Hematologic Disorders

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.
    

Eligibility criteria:

        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.