Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Paul G. Richardson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00378209
First received: September 18, 2006
Last updated: June 11, 2013
Last verified: June 2013

September 18, 2006
June 11, 2013
August 2006
July 2012   (final data collection date for primary outcome measure)
Evaluate time to progression following bortezomib, lenalidomide and dexamethasone combination therapy treatment in patients with relapsed or refractory multiple myeloma. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate time to progression following bortezomib, lenalidomide and dexamethasone combination therapy treatment in patients with relapsed or refractory multiple myeloma.
Complete list of historical versions of study NCT00378209 on ClinicalTrials.gov Archive Site
Evaluate the objective response rate, the duration of response, the progression free and overall survival, the tolerability and toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Evaluate the objective response rate, the duration of response, the progression free and overall survival, the tolerability and toxicity.
Not Provided
Not Provided
 
Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.

  • Participants will begin taking the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasts three weeks. They will take the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They will take dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and will come to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle is a rest period and the participant will not be taking any study medication.
  • Certain tests and procedures will be performed throughout each treatment cycle at definitive time periods. These tests include: medical history update, physical/neurological examination, skeletal survey (x-rays or scan), blood samples, urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT (if needed).
  • It is expected that participants will complete at least 8 cycles of the study, which adds up to 168 days. If the participant completes the first 8 cycles, has stable or responding disease and has not experienced bad side effects, they will be allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Bortezomib
    Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
  • Drug: Lenalidomide
    Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
  • Drug: Dexamethasone
    Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
Experimental: lenalidomide, dexamethasone, bortezomib combination
Participants will begin taking the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasts three weeks. They will take the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They will take dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and will come to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle is a rest period and the participant will not be taking any study medication.
Interventions:
  • Drug: Bortezomib
  • Drug: Lenalidomide
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
December 2014
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
  • Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior regimens
  • Negative serum or urine pregnancy test
  • Age 18 years or older
  • Karnofsky performance status of 60 or greater

Exclusion Criteria:

  • Grade 2 or greater peripheral neuropathy within 14 days before enrollment
  • Renal insufficiency (serum creatinine > 2.5 mg/dL)
  • Evidence of mucosal or internal bleeding and/or platelet refractory
  • ANC < 1000 cells/mm3
  • Hemoglobin < 8.0 g/dL
  • AST or ALT greater than or equal to 2 x ULN
  • Concomitant therapy medications that include corticosteroids
  • Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Clinically relevant active infection or serious co-morbid medical conditions
  • Prior malignancy (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer
  • Pregnant or breast-feeding
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Uncontrolled diabetes mellitus
  • Hypersensitivity to acyclovir or similar anti-viral drug
  • POEMS syndrome
  • Known HIV infection
  • Known active hepatitis B or C viral infection
  • Known intolerance to steroid therapy
  • Subjects with primary refractory disease, defined as progression during initial treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00378209
06-147
Not Provided
Paul G. Richardson, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Celgene Corporation
  • Millennium Pharmaceuticals, Inc.
Principal Investigator: Paul Richardson, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP