CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 273 enrolled
Drug / intervention
Lenalidomidedrug
Likely dose
Lenalidomide 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02322320
NCT02322320Phase 3Completed
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Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Dec 23, 2014·Updated May 11, 2020

In Brief

A Phase 3 clinical trial evaluating Lenalidomide for Multiple Myeloma. Completed, enrolled 273 participants across 42 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsBlood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 23, 2014
Enrollment StartMar 1, 2015
Primary CompletionJun 7, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.5 years ago

Interventions

Lenalidomidedrug

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.