Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Dana-Farber Cancer Institute.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00378209
First received: September 18, 2006
Last updated: March 4, 2011
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
Lenalidomide
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 64 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 of 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378209
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Paul Richardson, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Paul Richardson, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00378209 History of Changes |
| Other Study ID Numbers: | 06-147 |
| Study First Received: | September 18, 2006 |
| Last Updated: | March 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
relapsed multiple myeloma refractory 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 May 23, 2013