Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Pharmaceutical / Industry CR004579 NCT00097981

Trial Description

Summary

The main purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating patients newly diagnosed with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (also called "Complete Response") will be studied to make the determination of which treatment is more effective.

Further Study Information

The established treatment for newly diagnosed multiple myeloma is vincristine + adriamycin + intermittent high-dose dexamethasone therapy, but it requires a 96-hour continuous infusion of conventional doxorubicin. Newer options can be administered in an out-patient setting, which is more convenient for patients. However, the optimal regimen in producing a high rate of complete response and durable response remains to be established. This is a multi-center, open-label, randomized (patients are assigned different treatment sbased on chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone vs. DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4-12 cycles, depending on the response of their multiple myeloma to the treatment they receive (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Thalidomide + Dexamethasone treatment is as follows: Thalidomide by mouth every night without food on Days 1-28. Dosing will be gradually increased during Cycle 1: 50 mg on Days 1-7, 100 mg on Days 8-14, 150 mg on Days 15-21, and 200 mg on Days 22-28. Thereafter, 200 mg daily will be administered for all subsequent cycles. Dexamethasone will be given at 40 mg by mouth on Days 1-4, Days 9-12 and Days 17-20. DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone treatment is as follows: Thalidomide and Dexamethasone will be administered in the same way as described for the Thalidomide + Dexamethasone treatment group. DOXIL (doxorubicin HCl liposome injection) will be administered on Day 1 via intravenous infusion of 40 mg/m2 over 60 minutes (Cycle 1 infusion is over 90 minutes). Patients will be assessed for safety and efficacy by standard evaluations for patients with multiple myeloma at each cycle. Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection) . The study hypothesis is that the DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone treatment will be more effective in the treatment of newly diagnosed multiple myeloma than the Thalidomide + Dexamethasone treatment, as measured by number of complete responses and will be generally well-tolerated.

Specific dose adjustments can be made to Thalidomide and/or DOXIL (doxorubicin HCl liposome injection) based upon toxicity. Maximum duration of study participation for patients would be 48 weeks.

Eligibility Criteria

Inclusion Criteria:

• Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group [IMWG] criteria

• Eastern Cooperative Oncology Group (ECOG) status 0-2

• Adequate absolute neutrophil count (ANC), platelet count and hemoglobin

• Adequate serum calcium

• Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.)

Exclusion Criteria:

• No treatment with dexamethasone for multiple myeloma

• No peripheral neuropathy of Grade 2 or higher

• No Left Ventricular Ejection Fraction (LVEF) of < 45%

• No history of life-threatening thromboembolic events of any kind (i.e., myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study

• No deep vein thrombosis (DVT) within 1 year of enrollment

• No current anticoagulation for DVT

Trial Contact Information

Trial Lead Organizations/Sponsors

Johnson & Johnson Pharmaceutical Research & Development, LLC

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00097981
Information obtained from ClinicalTrials.gov on September 30, 2008