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

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lenalidomide

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Lenalidomide, Maintenance Therapy, Progression, Long-term, Anti-Myeloma Agents, Hematologic Disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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:

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.

Sites / Locations

Arizona Cancer Center
City of Hope National Medical Center
University of California, San Diego Medical Center
Stanford Hospital and Clinics
Colorado Blood Cancer Institute
University of Florida College of Medicine
University of Miami
H. Lee Moffitt Cancer Center
BMT Group of Georgia (Northside Hospital)
Rush University Medical Center
University of Kansas Hospital
Louisiana State University Health Sciences Center
DFCI, Brigham and Womens Hospital
University of Michigan Medical Center
Karmanos Cancer Institute/BMT
University of Minnesota
Washington University, Barnes Jewish Hospital
University of Nebraska Medical Center
Hackensack University Medical Center
Roswell Park Cancer Center
North Shore University Hospital
Mount Sinai Medical Center
Memorial Sloan-Kettering Cancer Center
University of North Carolina Hospital at Chapel Hill
Duke University Medical Center
Wake Forest University Health Sciences
Jewish Hospital BMT Program
University Hospitals of Cleveland/Case Western
Ohio State/Arthur G. James Cancer Hospital
University of Oklahoma Medical Center
Oregon Health & Science University
Penn State College of Medicine, The Milton S. Hershey Medical Center
University of Pennsylvania Cancer Center
Sarah Cannon Blood & Marrow Transplant Program
Vanderbilt University Medical Center
University of Texas Southwestern Medical Center
University of Texas/MD Anderson CRC
Texas Transplant Institute
Fred Hutchinson Cancer Research Center
West Virginia University Hospital
University of Wisconsin Hospital & Clinics
Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Tandem Auto Transplant

RVD Consolidation

Lenalidomide Maintenance

Arm Description

Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

Initial autologous transplant followed by lenalidomide maintenance

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02322320

First Posted

December 17, 2014

Last Updated

April 27, 2020

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

1. Study Identification

Unique Protocol Identification Number

NCT02322320

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

June 7, 2019 (Actual)

Study Completion Date

June 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

273 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tandem Auto Transplant

Arm Type

Active Comparator

Arm Description

Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

Arm Title

RVD Consolidation

Arm Type

Active Comparator

Arm Description

Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

Arm Title

Lenalidomide Maintenance

Arm Type

Active Comparator

Arm Description

Initial autologous transplant followed by lenalidomide maintenance

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid™

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With Progression-free Survival (PFS)

Description

Time Frame