Daratumumab + Bortezomib/Dexamethasone & Ixazomib for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byHans Lee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well daratumumab, bortezomib, and dexamethasone followed by daratumumab, ixazomib, and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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. Bortezomib and ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab, bortezomib, and dexamethasone followed by daratumumab, ixazomib, and dexamethasone may work better and help to control cancer in patients with multiple myeloma.

Eligibility Criteria

This trial is for patients with multiple myeloma that has returned or hasn't responded to treatment. Participants must have had 1-3 prior treatments and shown some response, be in fair health (ECOG 0-2), agree to use contraception, and have measurable disease. They can't join if they've had certain drugs like ixazomib before, are allergic to study drugs, plan on having a stem cell transplant soon, or have other serious medical conditions.

Inclusion Criteria

My condition improved after previous cancer treatment.

I have been diagnosed with multiple myeloma through a biopsy.

I have had 1 to 3 treatment plans for my multiple myeloma.

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Exclusion Criteria

I have not had radiotherapy within the specified time before joining.

I haven't taken strong CYP3A inducers or St. John's wort in the last 14 days.

I recently finished my multiple myeloma treatment.

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Treatment Details

Interventions

Bortezomib (Proteasome Inhibitor)
Daratumumab (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)
Ixazomib (Proteasome Inhibitor)

Trial OverviewThe trial tests daratumumab with bortezomib and dexamethasone followed by daratumumab with ixazomib and dexamethasone in relapsed/refractory multiple myeloma patients. It examines whether this combination helps control the cancer better than previous treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab, bortezomib, dexamethasone, ixazomib)Experimental Treatment5 Interventions

Patients receive daratumumab IV over 3.5-6.5 hours on days 1, 8, and 15, bortezomib SC on days 1, 4, 8, and 11, and dexamethasone IV over 15 minutes on days 1, 8, and 15 and PO on days 2, 4, 5, 9, 11, 12, and 16. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive daratumumab IV over 3.5 hours on days 1 and 15 of cycles 4-7 and day 1 of subsequent cycles, ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO once weekly. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: