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

Description

The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have not been approved in the combination for multiple myeloma or any other type of cancer. Bortezomib is currently approved by the FDA for the treatment of multiple myeloma. Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Please note that Bortezomib and Lenalidomide are provided to patients participating in this trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma studies and information from those studies suggests that this combination of therapy may help to treat newly diagnosed multiple myeloma.

In this research study, the investigators 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 Start Date

September 2010

Estimated Completion Date

September 2018

Interventions

  • Drug: Bortezomib
  • Procedure: Autologous Stem Cell Transplant
  • Drug: Lenalidomide
  • Drug: Dexamethasone

Specialties

  • Oncology: BMT/SCT,Leukemia/Lymphoma,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology

MeSH Terms

  • Multiple Myeloma

Study ID

Dana-Farber Cancer Institute -- 10-106

Status

Unknown

Trial ID

NCT01208662

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

660

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic 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 Negative HIV blood test
  • Voluntary written informed consent

Exclusion Criteria

  • Pregnant or lactating female
  • Prior systemic therapy for MM (localized radiotherapy allowed if >/= 2 weeks before study entry, corticosteroids allowed if dose 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 >2.5 mg/dl or creatinine clearance <60 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
  • Inability to comply with an anti-thrombotic treatment regimen
  • Peripheral neuropathy >/= Grade 2

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (48)

Study Location Distance Name Phone Email
North Shore Long Island Jewish Health System - Lake Success, New York 39.6 miles RutheeLu Bayer MD 516-734-8476 rbayer@nshs.edu
Columbia University - New York, New York 44.8 miles Suzanne Lentzch MD 212-342-3849 sl3440@cumc.columbia.edu
Mount Sinai Medical Center - New York, New York 46.8 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 48.5 miles Hani Hassoun MD None None
Memorial Sloan Kettering Cancer Center - New York, New York 48.5 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles None None None
University of Pennsylvania Medical Center - Philadelphia, Pennsylvania 134.5 miles Adam D Cohen MD 215-615-5853 adam.cohen@uphs.upenn.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 135.7 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 135.7 miles David Avigan MD 617-667-9920 davigan@bidmc.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 135.8 miles Paul Richardson MD 617-632-2104 Paul_Richardson@dfci.harvard.edu
Dana-Farber Cancer Institute - Boston, Massachusetts 135.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
Cape Cod Healthcare - Hyannis, Massachusetts 156.5 miles None None None
University of Rochester Medical Center - Rochester, New York 260.4 miles Michael W Becker MD 585-273-3968 Michael_Becker@URMC.Rochester.edu
Roswell Park Cancer Institute - Buffalo, New York 310.8 miles None None None
Eastern Maine Medical Center - Brewer, Maine 336.2 miles Thomas Openshaw MD None topenshaw@emh.org
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 354.1 miles Mounzer Agha MD 412-235-1020 Aghame@upmc.edu
Duke University - Durham, North Carolina 474.7 miles None None None
UNC Lineberger Comprehensive Cancer Center - Chapel Hill, North Carolina 482.1 miles None None None
UNC Lineberger Comprehensive Cancer Center - Chapel Hill, North Carolina 482.1 miles Peter Voorhees MD 919-966-5879 peter_voorhees@med.unc.edu
Barbara Ann Karmanos Cancer Institute - Detroit, Michigan 512.3 miles None None None
Ohio State University Medical Center - Columbus, Ohio 520.3 miles Yvonne Efebera MD 614-366-0372 None
Wake Forest University - Winston-Salem, North Carolina 523.1 miles None None None
University of Michigan - Ann Arbor, Michigan 545.4 miles None None None
University of Chicago - Chicago, Illinois 744.7 miles None None None
University of Chicago - Chicago, Illinois 744.7 miles None None None
Emory University - Atlanta, Georgia 795.6 miles None None None
Emory University - Atlanta, Georgia 795.6 miles Sagar Lonial MD 404-727-5572 sloni01@emory.edu
Vanderbilt University - Nashville, Tennessee 810.5 miles Frank Cornell MD 615-875-6120 robert.f.cornell@vanderbilt.edu
University of Alabama at Birmingham - Birmingham, Alabama 916.1 miles Racquel Innis Shelton MD 205-975-3371 Rishelton@uabmc.edu
University of Florida - Gainesville, Florida 954.8 miles Jan Moreb MD 352-273-6845 morebjs@medicine.ufl.edu
H Lee Moffitt Cancer Center - Tampa, Florida 1,050.4 miles Melisa Alsina MD 813-745-6886 melisa.alsina@moffitt.org
University of Mississippi Medical Center - Jackson, Mississippi 1,118.9 miles Tondre Buck MD 601-815-2005 tbuck@umc.edu
University of Mississippi Medical Center - Jackson, Mississippi 1,118.9 miles None None None
Ochsner Foundation Clinic - New Orleans, Louisiana 1,227.0 miles Robert Emmons MD 504-842-3910 Remmons@ochsner.org
University of Texas Southwestern Medical Center - Dallas, Texas 1,414.8 miles Larry Anderson MD 214-648-5906 Larry.Anderson@UTSouthwestern.edu
MD Anderson Cancer Center - Houston, Texas 1,475.7 miles None None None
Baylor College of Medicine - Houston, Texas 1,475.7 miles Rammurti Kamble MD 713-441-6769 RTKamble@houstonmethodist.org
Colorado Blood Cancer Institute - Denver, Colorado 1,665.3 miles Jeffrey V Matous MD 720-754-4800 Jeffrey.Matous@HealthONEcares.com
Arizona Comprehensive Cancer Center - Tucson, Arizona 2,164.2 miles Amit Agarwal MD 520-626-6542 aagarwal@uacc.arizona.edu
Mountain States Tumor Institute at St Lukes Regional Medical Center - Boise, Idaho 2,176.6 miles William H Kreisle 800-845-4624 None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,427.3 miles None None None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,427.3 miles William Bensinger MD 206-667-4933 wbensing@fhcrc.org
City of Hope - Duarte, California 2,472.0 miles Amrita Krishnan MD 626-256-4673 Akrishnan@coh.org
Stanford University - Stanford, California 2,599.9 miles None None None
Stanford University - Stanford, California 2,599.9 miles Michaela Liedtke MD 650-498-6000 mliedtke@standford.edu
University of California San Francisco - San Francisco, California 2,606.4 miles None None None
University of California, San Francisco - San Francisco, California 2,606.4 miles None None None

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