Lenalidomide + Dexamethasone +/- Thalidomide for Multiple Myeloma

Recruiting at153 trial locations

Overseen by S. V Rajkumar

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if lenalidomide with either standard or low-dose dexamethasone works better for new multiple myeloma patients. If not, thalidomide is added. The goal is to find effective treatments with fewer side effects. Lenalidomide plus low-dose dexamethasone has been shown to be an effective treatment for multiple myeloma, particularly in patients who are not candidates for stem cell transplantation.

Research Team

S. V Rajkumar

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults recently diagnosed with symptomatic multiple myeloma. They should have certain blood and marrow conditions, not be pregnant or breastfeeding, and can't have had previous systemic therapy for the disease (except bisphosphonates). People with severe illnesses, uncontrolled infections, a history of blood clots without anticoagulation therapy, or significant neuropathy cannot join.

Inclusion Criteria

I have had cancer before but meet specific conditions for this trial.

I am able to care for myself and perform daily activities.

I was diagnosed with multiple myeloma recently and have symptoms.

Exclusion Criteria

I do not have any serious illnesses that are not under control.

I have never had deep vein thrombosis or a pulmonary embolism.

I do not have severe numbness or pain in my hands or feet.

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• Lenalidomide (Immunomodulatory Agent)
• Thalidomide (Immunomodulatory Agent)

Trial Overview The study compares lenalidomide combined with low or standard doses of dexamethasone against the same regimen plus thalidomide in treating multiple myeloma. It aims to see which combination is more effective at stopping cancer growth by affecting the immune system and cutting off cancer's blood supply.

Participant Groups

Group I: Arm IV (thalidomide, low-dose dexamethasone) Experimental Treatment 3 Interventions

Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

Group II: Arm II (lenalidomide, low-dose dexamethasone) Experimental Treatment 3 Interventions

Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

Group III: Arm III (thalidomide, dexamethasone) Active Control 3 Interventions

Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20

Group IV: Arm I (lenalidomide, dexamethasone) Active Control 3 Interventions

Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

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?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School