Clinical Trial: NCT02322320 - My Cancer Genome

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:

Completed

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02322320

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

Drug	Synonyms	Arms
Lenalidomide	Revlimid™	Lenalidomide Maintenance

Purpose

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

Name	Type	Description	Interventions
Tandem Auto Transplant	Active Comparator	Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance	Lenalidomide
RVD Consolidation	Active Comparator	Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance	Lenalidomide
Lenalidomide Maintenance	Active Comparator	Initial 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:	Percentage of Participants With Progression-free Survival (PFS)
Time Frame:	5 years post-randomization in BMT CTN 0702
Safety Issue:
Description:	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.

Secondary Outcome Measures

Measure:	Percentage of Participants With Overall Survival (OS)
Time Frame:	5 years post-randomization in BMT CTN 0702
Safety Issue:
Description:	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.

Measure:	Percentage of Participants With Event-free Survival (EFS)
Time Frame:	5 years post-randomization in BMT CTN 0702
Safety Issue:
Description:	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.

Measure:	Percentage of Participants With Secondary Primary Malignancies (SPM)
Time Frame:	5 years post-randomization in BMT CTN 0702
Safety Issue:
Description:	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.

Measure:	Percentage of Participants With Disease Progression
Time Frame:	5 years post-randomization in BMT CTN 0702
Safety Issue:
Description:	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.

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Completed
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

May 11, 2020

Clinical Trials /

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