A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: DOXIL

Drug: Thalidomide

Drug: Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00097981

DO04-23-006 (Other Identifier)

CR004579

Details and patient eligibility

About

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

Full description

This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus 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 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). 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). Maximum duration of study participation for each participant will be 48 weeks.

Enrollment

225 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 less than 45 percentage
No history of life-threatening thromboembolic events of any kind (ie, 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