Bortezomib/Carfilzomib + Lenalidomide + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+919 other locations

Overseen by Shaji Kumar

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma

Research Team

Shaji Kumar

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for newly diagnosed multiple myeloma patients who've had certain prior chemotherapies but not treatments for symptomatic myeloma. They must agree to specific programs, meet contraceptive requirements, and have acceptable organ function and blood counts. HIV+ individuals can join if they meet extra criteria.

Inclusion Criteria

I had cancer before but meet the specific criteria for this trial.

I have had blood clots but am willing to take blood thinners if not already.

I have been diagnosed with a type of blood cancer called multiple myeloma and it's causing symptoms.

Exclusion Criteria

Pregnant women

I have not received treatments outside of my assigned therapy, including stem cell transplant.

I am currently breastfeeding.

Treatment Details

Interventions

• Bortezomib (Proteasome Inhibitor)
• Carfilzomib (Proteasome Inhibitor)
• Dexamethasone (Corticosteroid)
• Lenalidomide (Immunomodulatory Agent)

Trial Overview The study compares two drug combinations: Bortezomib with Lenalidomide and Dexamethasone versus Carfilzomib with the same drugs. It aims to find out which combination is more effective in stopping cancer cell growth by blocking enzymes or boosting the immune system.

Participant Groups

Group I: Arm D (lenalidomide) Experimental Treatment 3 Interventions

Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (lenalidomide) Experimental Treatment 3 Interventions

Patients receive lenalidomide PO daily on days 1-21. Treatment repeats every 4 weeks for 24 courses in the absences of disease progression or unacceptable toxicity.

Group III: Arm B (carfilzomib, lenalidomide, dexamethasone) Experimental Treatment 5 Interventions

Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16; lenalidomide PO daily on days 1-21; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (bortezomib, lenalidomide, dexamethasone) Experimental Treatment 5 Interventions

Patients receive bortezomib SC or IV on days 1, 4, 8, and 11 of courses 1-8 and days 1 and 8 of courses 9-12; lenalidomide PO daily on days 1-14; and dexamethasone PO daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of courses 1-8 and days 1, 2, 8, and 9 of courses 9-12. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

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

Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Dr. Peter J. O'Dwyer

ECOG-ACRIN Cancer Research Group

Chief Executive Officer since 2012

MD from University of Pennsylvania

Dr. Mitchell D. Schnall

ECOG-ACRIN Cancer Research Group

Chief Medical Officer since 2012

MD, PhD from University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

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