CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 729 enrolled
Drug / intervention
Lenalidomide +3 moredrug
Likely dose
Dexamethasone 20 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/NCT01208662
NCT01208662Phase 3Active
CompareCT.gov

A Randomized, Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib, and Dexamethasone (RVD) to High-Dose Treatment With Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients Up to 65 Years of Age

Paul Richardson, MD·interventional·Posted Sep 24, 2010·Updated Jan 22, 2026

In Brief

A Phase 3 clinical trial evaluating Lenalidomide, Bortezomib, and 2 other interventions for Multiple Myeloma. Active but no longer recruiting, targeting 729 participants across 46 sites.

Detailed Summary

In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsCelgene Corporation, Millennium Pharmaceuticals, Inc., Massachusetts General Hospital, Cape Cod Hospital, Beth Israel Deaconess Medical Center, Emory University, University of Michigan, Fox Chase Cancer Center, Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Center, Barbara Ann Karmanos Cancer Institute, Duke University, University of California, San Francisco, University of Chicago, M.D. Anderson Cancer Center, UNC Lineberger Comprehensive Cancer Center, Roswell Park Cancer Institute, Stanford University, University of Mississippi Medical Center, Icahn School of Medicine at Mount Sinai, Wake Forest University Health Sciences, University of Arizona, OHSU Knight Cancer Institute, Eastern Maine Medical Center, University of California, San Diego, University of Alabama at Birmingham, University of Pittsburgh Medical Center, Ochsner Health System, University of Texas Southwestern Medical Center, State University of New York - Downstate Medical Center, Newton-Wellesley Hospital, Baylor College of Medicine, City of Hope Medical Center, University of Florida, Northwell Health, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt University Medical Center, Ohio State University, Huntsman Cancer Institute, Columbia University

Timeline

Phase 3Active
20112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2010
Enrollment StartSep 1, 2010
Primary CompletionFeb 1, 2022
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 15.8 years ago

Interventions

Lenalidomidedrug

oral administration

Bortezomibdrug

intravenous or, following protocol amendment, subcutaneous administration

Dexamethasonedrug

oral administration Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.

Autologous Stem Cell Transplantprocedure

Autologous refers to stem cells that are harvested from the participant to be a source of new blood cells after high-dose chemotherapy with melphalan.