NCT02322320 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2020-05-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Progression-free Survival (PFS)

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outcome · POSTED

Percentage of Participants With Overall Survival (OS)

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outcome · POSTED

Percentage of Participants With Event-free Survival (EFS)

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outcome · POSTED

Percentage of Participants With Secondary Primary Malignancies (SPM)

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outcome · POSTED

Percentage of Participants With Disease Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
intervention Names
Drug: Lenalidomide
label
Tandem Auto Transplant
type
ACTIVE_COMPARATOR
description
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
intervention Names
Drug: Lenalidomide
label
RVD Consolidation
type
ACTIVE_COMPARATOR
description
Initial autologous transplant followed by lenalidomide maintenance
intervention Names
Drug: Lenalidomide
label
Lenalidomide Maintenance
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Lenalidomide Maintenance
RVD Consolidation
Tandem Auto Transplant
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.
name
Lenalidomide
other Names
Revlimid™
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 273
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Percentage of Participants With Progression-free Survival (PFS)
time Frame
5 years post-randomization in BMT CTN 0702

secondary Outcomes

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 Overall Survival (OS)
time Frame
5 years post-randomization in BMT CTN 0702
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 Event-free Survival (EFS)
time Frame
5 years post-randomization in BMT CTN 0702
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 Secondary Primary Malignancies (SPM)
time Frame
5 years post-randomization in BMT CTN 0702
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.
measure
Percentage of Participants With Disease Progression
time Frame
5 years post-randomization in BMT CTN 0702

Full 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).

Source references