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

NCT ID: NCT00378209

Last Updated: 2016-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2016-10-31

Brief Summary

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.

Detailed Description

• Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
• Certain tests and procedures were performed throughout each treatment cycle at definitive time periods. These tests included: 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 was expected that participants were going to complete at least 8 cycles of the study, which adds up to 168 days. If the participant completed the first 8 cycles, had stable or responding disease and had not experienced bad side effects, they were allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.

Conditions

Multiple Myeloma

Keywords

relapsed multiple myeloma; refractory multiple myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lenalidomide, dexamethasone, bortezomib combination

Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.

Lenalidomide

Intervention Type: DRUG

Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles

Dexamethasone

Intervention Type: DRUG

Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles

Interventions

Bortezomib

Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.

Intervention Type: DRUG

Lenalidomide

Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Paul G. Richardson, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Richardson, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Richardson PG, Xie W, Jagannath S, Jakubowiak A, Lonial S, Raje NS, Alsina M, Ghobrial IM, Schlossman RL, Munshi NC, Mazumder A, Vesole DH, Kaufman JL, Colson K, McKenney M, Lunde LE, Feather J, Maglio ME, Warren D, Francis D, Hideshima T, Knight R, Esseltine DL, Mitsiades CS, Weller E, Anderson KC. A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma. Blood. 2014 Mar 6;123(10):1461-9. doi: 10.1182/blood-2013-07-517276. Epub 2014 Jan 15.

Reference Type: DERIVED

PMID: 24429336 (View on PubMed)

Other Identifiers

06-147

Identifier Type: -

Identifier Source: org_study_id