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

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

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

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

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• DOXIL (Anti-tumor antibiotic)
• Thalidomide (Immunomodulatory Agent)

Participant Groups

Group I: Thalidomide + dexamethasone + DOXIL Experimental Treatment 3 Interventions

Group II: Thalidomide + dexamethasone Active Control 2 Interventions

Dexamethasone is already approved in Canada, Japan for the following indications:

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

515

Recruited

845,000+

Joaquin Duato

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

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. John Reed

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

Chief Medical Officer since 2023

MD from the University of Pennsylvania School of Medicine

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

Industry Sponsor

Trials

15

Recruited

3,100+