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
  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: 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:


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 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:
  • 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 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
  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 G. Richardson, MD, Principle Investigator, 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: June 11, 2013
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 April 17, 2014