Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

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.

Conditions

• Multiple Myeloma

Interventions

DRUG

Lenalidomide

oral administration

DRUG

Bortezomib

intravenous or, following protocol amendment, subcutaneous administration

DRUG

Dexamethasone

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

PROCEDURE

Autologous Stem Cell Transplant

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.

Sponsors & Collaborators

• Celgene Corporation

  collaborator INDUSTRY

• Millennium Pharmaceuticals, Inc.

  collaborator INDUSTRY

• Massachusetts General Hospital

  collaborator OTHER

• Cape Cod Hospital

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Fox Chase Cancer Center

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Barbara Ann Karmanos Cancer Institute

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• UNC Lineberger Comprehensive Cancer Center

  collaborator OTHER

• Roswell Park Cancer Institute

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• OHSU Knight Cancer Institute

  collaborator OTHER

• Eastern Maine Medical Center

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• State University of New York - Downstate Medical Center

  collaborator OTHER

• Newton-Wellesley Hospital

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• City of Hope Medical Center

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Northwell Health

  collaborator OTHER

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Huntsman Cancer Institute

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Paul Richardson, MD

  lead OTHER

Principal Investigators

• Paul G. Richardson, MD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2022-02-28

Completion

2026-12-31

Countries

• United States

Study Locations