Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
NCT ID: NCT01208662
Last Updated: 2026-01-22
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
729 participants
INTERVENTIONAL
2010-09-30
2026-12-31
Brief Summary
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Detailed Description
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After screening procedures determine if a patient is eligible for this research study, the patient will be randomized into one of the study groups: lenalidomide, bortezomib and dexamethasone without autologous stem cell transplantation, followed by lenalidomide maintenance (Arm A) or lenalidomide, bortezomib and dexamethasone with autologous stem cell transplantation, followed by lenalidomide maintenance (Arm B). There is an equal chance of being placed in either group. Randomization was stratified by International Staging System (ISS) disease stage (I, II, or III) and cytogenetics (high-risk \[presence of 17p deletion, t(4;14), or t(14;16) on fluorescence in-situ hybridization\], standard-risk \[absence of high-risk abnormalities\], or undetermined \[test failure\]) assessed locally in a screening bone marrow sample, with positivity cut-offs per institutional standards.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RVD Alone
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.
RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
Lenalidomide
oral administration
Bortezomib
intravenous or, following protocol amendment, subcutaneous administration
Dexamethasone
oral administration
Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.
RVD plus ASCT
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.
After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.
RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
Lenalidomide
oral administration
Bortezomib
intravenous or, following protocol amendment, subcutaneous administration
Dexamethasone
oral administration
Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.
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.
Interventions
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Lenalidomide
oral administration
Bortezomib
intravenous or, following protocol amendment, subcutaneous administration
Dexamethasone
oral administration
Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration
* Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
* ECOG performance status \</= 2
* Negative HIV blood test
* Voluntary written informed consent
Exclusion Criteria
* Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose \</= equivalent of 160 mg dexamethasone over 2 weeks)
* Primary amyloidosis (AL) or myeloma complicated by amylosis
* Receiving any other investigational agents
* Known brain metastases
* Poor tolerability or allergy to any of the study drugs or compounds of similar composition
* Platelet count \<50,000/mm3, within 21 days of registration
* ANC \<1,000 cells/mm3, within 21 days of registration
* Hemoglobin \<8 g/dL, within 21 days of registration
* Hepatic impairment (\>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline phosphatase \>2 x ULN). Patients with benign hyperbilirubinemia are eligible.
* Renal insufficiency (serum creatinine \>2.0 mg/dl or creatinine clearance \<50 ml/min, within 21 days of registration)
* Respiratory compromise (DLCO \< 50%)
* Clinical signs of heart or coronary failure or LVEF \< 40%. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities
* Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements
* Previous history of another malignant condition except for basal cell carcinoma and stage I cervical cancer. If malignancy was experienced more than 2 years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion.
* Inability to comply with an anti-thrombotic treatment regimen
* Peripheral neuropathy \>/= Grade 2
18 Years
65 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Millennium Pharmaceuticals, Inc.
INDUSTRY
Massachusetts General Hospital
OTHER
Cape Cod Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Emory University
OTHER
University of Michigan
OTHER
Fox Chase Cancer Center
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Fred Hutchinson Cancer Center
OTHER
Barbara Ann Karmanos Cancer Institute
OTHER
Duke University
OTHER
University of California, San Francisco
OTHER
University of Chicago
OTHER
M.D. Anderson Cancer Center
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER
Roswell Park Cancer Institute
OTHER
Stanford University
OTHER
University of Mississippi Medical Center
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Wake Forest University Health Sciences
OTHER
University of Arizona
OTHER
OHSU Knight Cancer Institute
OTHER
Eastern Maine Medical Center
OTHER
University of California, San Diego
OTHER
University of Alabama at Birmingham
OTHER
University of Pittsburgh Medical Center
OTHER
Ochsner Health System
OTHER
University of Texas Southwestern Medical Center
OTHER
State University of New York - Downstate Medical Center
OTHER
Newton-Wellesley Hospital
OTHER
Baylor College of Medicine
OTHER
City of Hope Medical Center
OTHER
University of Florida
OTHER
Northwell Health
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Vanderbilt University Medical Center
OTHER
Ohio State University
OTHER
Huntsman Cancer Institute
OTHER
Columbia University
OTHER
Paul Richardson, MD
OTHER
Responsible Party
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Paul Richardson, MD
Principal Investigator
Principal Investigators
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Paul G. Richardson, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Comprehensive Cancer Center
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
University of California at San Diego
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
University of Chicago
Chicago, Illinois, United States
Ochsner Foundation Clinic
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Brewer, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cape Cod Healthcare
Hyannis, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
New Hampshire Oncology and Hematology
Concord, New Hampshire, United States
New Hampshire Oncology and Hematology
Hooksett, New Hampshire, United States
New Hampshire Oncology and Hematology
Laconia, New Hampshire, United States
State University of New York Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore Long Island Jewish Health System
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Health and Sciences
Portland, Oregon, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Richardson PG, Jacobus SJ, Weller EA, Hassoun H, Lonial S, Raje NS, Medvedova E, McCarthy PL, Libby EN, Voorhees PM, Orlowski RZ, Anderson LD Jr, Zonder JA, Milner CP, Gasparetto C, Agha ME, Khan AM, Hurd DD, Gowin K, Kamble RT, Jagannath S, Nathwani N, Alsina M, Cornell RF, Hashmi H, Campagnaro EL, Andreescu AC, Gentile T, Liedtke M, Godby KN, Cohen AD, Openshaw TH, Pasquini MC, Giralt SA, Kaufman JL, Yee AJ, Scott E, Torka P, Foley A, Fulciniti M, Hebert K, Samur MK, Masone K, Maglio ME, Zeytoonjian AA, Nadeem O, Schlossman RL, Laubach JP, Paba-Prada C, Ghobrial IM, Perrot A, Moreau P, Avet-Loiseau H, Attal M, Anderson KC, Munshi NC; DETERMINATION Investigators. Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med. 2022 Jul 14;387(2):132-147. doi: 10.1056/NEJMoa2204925. Epub 2022 Jun 5.
Parmar H, Vesole DH, Biran N. From VAD to VRD: Is Transplant Still Needed in the Upfront Setting of Myeloma? Cancer J. 2021 May-Jun 01;27(3):190-195. doi: 10.1097/PPO.0000000000000522.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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10-106
Identifier Type: -
Identifier Source: org_study_id
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