Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Massachusetts General Hospital Celgene Corporation Millennium Pharmaceuticals, Inc.
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00378105

Purpose

The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Bortezomib Drug: Lenalidomide Drug: dexamethasone	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

Determine the maximum tolerated dose of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
evaluate the objective response rate of the drug combination in this patient populations. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the overall response rate after 4 and 8 cycles, the complete response rate, time to progression, duration of response, the overall survival and progression free survival and the tolerability and toxicity. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	87
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Intravenously on days 1, 4, 8 and 11 of a 21 day cycle for a minimum of 8 cycles (dosage will vary depending upon when the participant enters the trial)

Taken orally twice a day for 2 weeks (days 1-14) of each 21-day cycle for a minimum of 8 cycles (dosage will vary depending upon when participant enters trial).

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

Detailed Description:

The safe dose of dexamethasone is already known. The dose of bortezomib and lenalidomide will be increased during the study until the best and safest amount (or dose) is identified. The participant's dose of the study drugs will depend on when they enter the study.
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.
During the course of the study treatment, tests and procedures will be performed at designated time periods. This includes; medical history updates, physical/neurological examinations, skeletal survey (x-rays or scan), blood samples, optional bone marrow aspiration/tissue biopsy, urine samples, 12-lead ECG, and MRI/CT scan (if needed).
It is expected that study participants will receive study treatment for 8 cycles (168 days). If the participant completes the first 8 cycles of the study, 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:

Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
Negative serum or urine pregnancy test
Age 18 years or older
Karnofsky performance status of greater or equal to 60

Exclusion Criteria:

Greater or equal to Grade 2 peripheral neuropathy on clinical examination 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 according to NYHY 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 except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
Pregnant or breast-feeding
Serious medical or psychiatric illness likely to interfere with participation in 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378105

Contacts

Contact: Paul Richardson, MD

617-632-2104

prichardson@partners.org

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Deborah Doss, RN 617-632-5672
Sub-Investigator: Kenneth Anderson, MD
Sub-Investigator: Irene Ghobrial, MD
Sub-Investigator: Nikhil Munshi, MD
Sub-Investigator: Robert Schlossman, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: David Avigan, MD
Sub-Investigator: Robin Joyce, MD
Sub-Investigator: James Levine, MD
Sub-Investigator: Kenneth Miller, MD
Sub-Investigator: Jacalyn Rosenblatt, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Sub-Investigator: Noopur Raje, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Celgene Corporation

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Paul Richardson, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Paul Richardson, MD )
Study ID Numbers:	06-150
Study First Received:	September 18, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00378105
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

newly diagnosed multiple myeloma

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Lenalidomide
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Enzyme Inhibitors

Hormones
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009