Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Celgene Corporation Millennium Pharmaceuticals, Inc.
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00378209

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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Bortezomib Lenalidomide CC 5013 Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

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:	August 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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 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:	Dana-Farber Cancer Institute ( Paul Richardson, MD )
Study ID Numbers:	06-147
Study First Received:	September 18, 2006
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00378209 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

relapsed multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Blood Protein Disorders
Hematologic Diseases
Hormone Antagonists
Blood Coagulation Disorders
Bortezomib
Hormones, Hormone Substitutes, and Hormone Antagonists
Lenalidomide
Vascular Diseases

Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Glucocorticoids
Protease Inhibitors
Multiple Myeloma
Hemorrhagic Disorders
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Dexamethasone acetate

Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Bortezomib
Gastrointestinal Agents
Vascular Diseases
Lenalidomide
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009