Trial record 1 of 1 for:    NCT01208662
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Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Massachusetts General Hospital
Cape Cod Healthcare
Beth Israel Deaconess Medical Center
Emory University
University of Michigan
Fox Chase Cancer Center
Memorial Sloan-Kettering Cancer Center
Fred Hutchinson Cancer Research 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
Mount Sinai School of Medicine
Wake Forest Baptist Health
Information provided by (Responsible Party):
Paul G. Richardson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01208662
First received: September 23, 2010
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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, 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.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone
Procedure: Autologous Stem Cell Transplant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Primary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To compare progression-free survival (PFS) between Arm A and Arm B.


Secondary Outcome Measures:
  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To compare the response rates (RR) between the two arms.

  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To compare time to progression (TTP) between the two arms.

  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To compare the overall survival (OS) between the two arms.

  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: Yes ]
    To compare toxicity between the two arms.

  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To define genetic prognostic groups evaluated by gene expression profiling (GEP).

  • Secondary Outcomes [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To examine the best treatment in each GEP-defined prognostic group.

  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To compare quality of life (QOL) between the two arms.

  • Secondary Outcome [ Time Frame: Up to 6 years or until progression ] [ Designated as safety issue: No ]
    To collect medical resource utilization (MRU) information which may be used in economic evaluation models.


Estimated Enrollment: 660
Study Start Date: September 2010
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Dose Treatment
Lenalidomide, bortezomib, dexamethasone. Stem cell collection. Maintenance Lenalidomide.
Drug: Lenalidomide

Oral, 25 mg/day, days 1-14 for 8 total cycles for Arm A. Oral, 25 mg/day, days 1-14 for 5 total cycles for Arm B.

Oral, 10-15 mg/day, daily for 12 months in maintenance for Arm A and Arm B.

Other Name: CC-5013
Drug: Bortezomib
IV, days 1, 4, 8 and 11 for 8 total cycles for Arm A. IV, days 1, 4, 8 and 11 for 5 total cycles for Arm B.
Other Names:
  • PS-341
  • Velcade
Drug: Dexamethasone

Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 8 total cycles for Arm A. Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 5 total cycles for Arm B.

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

Other Name: Decadron
Experimental: High Dose Treatment with SCT
Lenalidomide, bortezomib, dexamethasone. Stem cell collection. Autologous Stem Cell Transplant. Maintenance Lenalidomide.
Drug: Lenalidomide

Oral, 25 mg/day, days 1-14 for 8 total cycles for Arm A. Oral, 25 mg/day, days 1-14 for 5 total cycles for Arm B.

Oral, 10-15 mg/day, daily for 12 months in maintenance for Arm A and Arm B.

Other Name: CC-5013
Drug: Bortezomib
IV, days 1, 4, 8 and 11 for 8 total cycles for Arm A. IV, days 1, 4, 8 and 11 for 5 total cycles for Arm B.
Other Names:
  • PS-341
  • Velcade
Drug: Dexamethasone

Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 8 total cycles for Arm A. Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 5 total cycles for Arm B.

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

Other Name: Decadron
Procedure: Autologous Stem Cell Transplant
Stem cell transplant

Detailed Description:

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.

All participants will receive one cycle of lenalidomide, bortezomib and dexamethasone treatment before being randomized to Arm A or Arm B.

Participants in Arm A will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. If randomized to Arm A, the subject will undergo stem cell collection, followed by five cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide maintenance treatment until disease progression.

Participants in Arm B will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. If randomized to Arm B, the subject will undergo stem cell collection and autologous stem cell transplantation, followed by two cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide maintenance treatment until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </= 2
  • 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 </= 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
  • Inability to comply with an anti-thrombotic treatment regimen
  • Peripheral neuropathy >/= Grade 2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208662

Contacts
Contact: Paul G Richardson, MD 617-632-2104 paul_richardson@dfci.harvard.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jeffrey Wolf, MD    415-353-2519    wolfj@medicine.ucsf.edu   
Principal Investigator: Jeffrey Wolf, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Michaela Liedtke, MD    650-498-6000    mliedtke@standford.edu   
Principal Investigator: Michaela Liedtke, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sagar Lonial, MD    404-727-5572    sloni01@emory.edu   
Principal Investigator: Sagar Lonial, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Todd Zimmerman, MD    733-702-4159    tzimmerm@medicine.bsd.uchicago.edu   
Principal Investigator: Todd Zimmerman, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul Richardson, MD    617-632-2104    Paul_Richardson@dfci.harvard.edu   
Principal Investigator: Paul Richardson, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Noopur Raje, MD    617-726-0711    nraje@partners.org   
Principal Investigator: Noopur Raje, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: David Avigan, MD    617-667-9920    davigan@bidmc.harvard.edu   
Principal Investigator: David Avigan, MD         
Cape Cod Healthcare Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Frank Basile, MD    508-862-5799    fgbasile@CapeCodHealth.org   
Principal Investigator: Frank Basile, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Daniel Couriel, MD       dcouriel@med.umich.edu   
Principal Investigator: Daniel Couriel, MD         
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey Zonder, MD    313-576-8730    zonderj@karmanos.org   
Principal Investigator: Jeffrey Zonder, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Tondre Buck, MD    601-815-2005    tbuck@umc.edu   
Principal Investigator: Tondre Buck, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Myron Czuczman, MD    716-845-4485    Myron.Czuczman@RoswellPark.org   
Principal Investigator: Myron Czuczman, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Hani Hassoun, MD         
Principal Investigator: Hani Hassoun, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Sundar Jagannath, MD    212-241-7873    sundar.jagannath@mountsinai.org   
Principal Investigator: Sundar Jagannath, MD         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Peter Voorhees, MD    919-966-5879    peter_voorhees@med.unc.edu   
Principal Investigator: Peter Voorhees, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Cristina Gasparetto, MD    919-668-1017    Gaspa001@mc.duke.edu   
Principal Investigator: Christina Gasparetto, MD         
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: David Hurd, MD    336-716-4464    dhurd@wakehealth.edu   
Principal Investigator: David Hurd, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Adam Cohen, MD    215-728-2674    adam.cohen@fccc.edu   
Principal Investigator: Adam Cohen, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michael Wang, MD    713-792-2860    miwang@mdanderson.org   
Principal Investigator: Michael Wang, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: William Bensinger, MD    206-667-4933    wbensing@fhcrc.org   
Principal Investigator: William Bensinger, MD         
Sponsors and Collaborators
Paul G. Richardson, MD
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Massachusetts General Hospital
Cape Cod Healthcare
Beth Israel Deaconess Medical Center
Emory University
University of Michigan
Fox Chase Cancer Center
Memorial Sloan-Kettering Cancer Center
Fred Hutchinson Cancer Research 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
Mount Sinai School of Medicine
Wake Forest Baptist Health
Investigators
Principal Investigator: Paul G. Richardson, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Paul G. Richardson, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01208662     History of Changes
Other Study ID Numbers: 10-106
Study First Received: September 23, 2010
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Lenalidomide
Bortezomib
Dexamethasone
Stem Cell Transplant
Myeloma
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 20, 2014