40 Participants Needed

Daratumumab + Bortezomib/Dexamethasone & Ixazomib for Multiple Myeloma

HL
Overseen ByHans Lee
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Research Team

Hans Lee | MD Anderson Cancer Center

Hans Lee, MD

Principal Investigator

M.D. Anderson Cancer Center

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.
See 7 more

Treatment Details

Interventions

  • Bortezomib
  • Daratumumab
  • Dexamethasone
  • Ixazomib
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:
  • Multiple myeloma
  • Mantle cell lymphoma
🇺🇸
Approved in United States as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
🇨🇦
Approved in Canada as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma
🇯🇵
Approved in Japan as Velcade for:
  • Multiple myeloma
  • Mantle cell lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Takeda

Industry Sponsor

Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota profile image

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber profile image

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier