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

NCT ID: NCT00097981

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-10-31

Brief Summary

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.

Detailed 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thalidomide + dexamethasone

Group Type: ACTIVE_COMPARATOR

Thalidomide

Intervention Type: DRUG

Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

Dexamethasone

Intervention Type: DRUG

Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.

Thalidomide + dexamethasone + DOXIL

Group Type: EXPERIMENTAL

Thalidomide

Intervention Type: DRUG

Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

Dexamethasone

Intervention Type: DRUG

Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.

DOXIL

Intervention Type: DRUG

DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.

Interventions

Thalidomide

Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.

Intervention Type: DRUG

Dexamethasone

Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.

Intervention Type: DRUG

DOXIL

DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.

Intervention Type: DRUG

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 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

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

Sponsors

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Fountain Valley, California, United States

Greenbrae, California, United States

La Verne, California, United States

Los Angeles, California, United States

Denver, Colorado, United States

New London, Connecticut, United States

Boca Raton, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orange City, Florida, United States

Ormond Beach, Florida, United States

Lawrenceville, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Wichita, Kansas, United States

Baltimore, Maryland, United States

Bethesda, Maryland, United States

Minneapolis, Minnesota, United States

Saint Louis Park, Minnesota, United States

Columbia, Missouri, United States

Kansas City, Missouri, United States

Omaha, Nebraska, United States

Englewood, New Jersey, United States

Hackensack, New Jersey, United States

Jersey City, New Jersey, United States

Voorhees Township, New Jersey, United States

Albany, New York, United States

Armonk, New York, United States

Box 302, New York, United States

Brooklyn, New York, United States

Nyack, New York, United States

The Bronx, New York, United States

Valhalla, New York, United States

Durham, North Carolina, United States

Winston-Salem, North Carolina, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Eugene, Oregon, United States

Pittsburgh, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Columbia, South Carolina, United States

Easley, South Carolina, United States

Sumter, South Carolina, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Bedford, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Fredericksburg, Texas, United States

Houston, Texas, United States

Burlington, Vermont, United States

Fairfax, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Spokane, Washington, United States

Vancouver, Washington, United States

Yakima, Washington, United States

Countries

United States

Other Identifiers

DO04-23-006

Identifier Type: OTHER

Identifier Source: secondary_id

CR004579

Identifier Type: -

Identifier Source: org_study_id