Clinical Trials /

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

NCT02322320

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
  • Official Title: Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)

Clinical Trial IDs

  • ORG STUDY ID: BMTCTN07LT
  • SECONDARY ID: U01HL069294-05
  • NCT ID: NCT02322320

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
LenalidomideRevlimidTandem Auto Transplant

Purpose

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.

Detailed 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).
    

Trial Arms

NameTypeDescriptionInterventions
Tandem Auto TransplantActive ComparatorInitial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
  • Lenalidomide
RVD ConsolidationActive ComparatorInitial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
  • Lenalidomide
Lenalidomide MaintenanceActive ComparatorInitial autologous transplant followed by lenalidomide maintenance
  • Lenalidomide

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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Compare the PFS as a time to event analysis from randomization on the BMT CTN 0702 protocol between the three randomized treatment arms as a pairwise comparison.
Time Frame:5 years post randomization on BMT CTN 0702
Safety Issue:
Description:The primary analysis will include all randomized subjects from the BMT CTN 0702 protocol, classified according to their randomized treatment allocation, irrespective of treatment actually received [intent-to-treat]. The time to this event is the time from randomization on the BMT CTN 0702 protocol to progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Patients will be censored at loss to follow-up or end of 2018, whichever comes first. Deaths without progression are treated as failures no matter when they occur. The analysis will be conducted once all living patients have been followed for 5-years post randomization on the BMT CTN 0702 protocol.

Secondary Outcome Measures

Measure:Overall survival from randomization on the BMT CTN 0702 protocol
Time Frame:5 years post randomization on BMT CTN 0702
Safety Issue:
Description:Overall survival (OS) time will be calculated as the time from randomization on the BMT CTN 0702 protocol to death, loss to follow-up or the end of the study, whichever comes first. Patients alive at the time of last observation or lost to follow-up will be censored at the date of last contact. OS will be compared between treatment arms.
Measure:Event-free survival from randomization on the BMT CTN 0702 protocol
Time Frame:5 years post randomization on BMT CTN 0702
Safety Issue:
Description:Event-free survival (EFS) will be calculated as the time from randomization on the BMT CTN 0702 protocol to death, progression, second primary malignancy, loss to follow-up or the end of the study, whichever comes first. Patients alive at the time of last observation of lost to follow-up will be censored at the date of last contact. EFS will be compared between treatment arms.
Measure:Unexpected Grades 3 - 5 adverse events
Time Frame:5 years post randomization on BMT CTN 0702
Safety Issue:
Description: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.
Measure:Health Quality of Life
Time Frame:5 years post randomization on BMT CTN 0702
Safety Issue:
Description:Health quality of life (HQL) will be compared between all treatment groups utilizing the FACT-BMT and SF-36.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Heart, Lung, and Blood Institute (NHLBI)

Trial Keywords

  • Multiple Myeloma
  • Lenalidomide
  • Maintenance Therapy
  • Progression
  • Long-term
  • Anti-Myeloma Agents
  • Hematologic Disorders

Last Updated

August 24, 2017