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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01208662

Public ClinicalTrials.gov record NCT01208662. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01208662
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Paul Richardson, MD
Other
Enrollment
729 participants

Conditions and interventions

Interventions

Drug · Procedure

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2010 (Type not available)
Primary completion
Feb 2022 (Actual)
Completion
Dec 2026 (Estimated)
Last update posted
Jan 22, 2026

2010 – 2026

United States locations

U.S. sites
46
U.S. states
23
U.S. cities
40
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Arizona Comprehensive Cancer Center Tucson Arizona 85724 —
City of Hope Duarte California 91010 —
University of California at San Diego La Jolla California — —
University of California, San Francisco San Francisco California 94143 —
Stanford University Stanford California 94305 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
University of Florida Gainesville Florida 32608 —
H. Lee Moffitt Cancer Center Tampa Florida 33612 —
Emory University Atlanta Georgia 30322 —
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho 83712 —
University of Chicago Chicago Illinois 60637 —
Ochsner Foundation Clinic New Orleans Louisiana 70121 —
Eastern Maine Medical Center Brewer Maine 04412 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Dana-Farber Cancer Institute Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Cape Cod Healthcare Hyannis Massachusetts 02601 —
Newton-Wellesley Hospital Newton Massachusetts — —
University of Michigan Ann Arbor Michigan 48109 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
New Hampshire Oncology and Hematology Concord New Hampshire — —
New Hampshire Oncology and Hematology Hooksett New Hampshire — —
New Hampshire Oncology and Hematology Laconia New Hampshire — —
State University of New York Downstate Medical Center Brooklyn New York — —
Roswell Park Cancer Institute Buffalo New York 14263 —
North Shore Long Island Jewish Health System Lake Success New York 11042 —
Memorial Sloan Kettering Cancer Center New York New York 10021 —
Mount Sinai Medical Center New York New York 10029 —
Columbia University New York New York 10032 —
University of Rochester Medical Center Rochester New York 14642 —
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 —
Duke University Durham North Carolina 27710 —
Wake Forest University Winston-Salem North Carolina 27157 —
Ohio State University Medical Center Columbus Ohio 43210 —
Oregon Health and Sciences Portland Oregon — —
University of Pennsylvania Medical Center Philadelphia Pennsylvania 19104 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15232 —
Vanderbilt University Nashville Tennessee 37203 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Baylor College of Medicine Houston Texas 77030 —
MD Anderson Cancer Center Houston Texas 77030 —
Huntsman Cancer Institute Salt Lake City Utah — —
Fred Hutchinson Cancer Research Center Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01208662, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 22, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01208662 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →