Daratumumab + Bortezomib/Dexamethasone & Ixazomib for Multiple Myeloma

Overseen By Hans Lee

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A inducers, St. John's wort

Disqualifiers: COPD, Cardiac issues, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

40 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Hans Lee, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive daratumumab, bortezomib, and dexamethasone for 3 cycles of 28 days each

12 weeks

Multiple visits per cycle for drug administration

Treatment Phase 2

Participants receive daratumumab, ixazomib, and dexamethasone starting from cycle 4, repeating every 28 days

Indefinite, until disease progression or unacceptable toxicity

Regular visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Follow-up at 30 days post-treatment, then periodically

What Are the Treatments Tested in This Trial?

Interventions

• Bortezomib
• Daratumumab
• Dexamethasone
• Ixazomib

Trial Overview The 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.

How Is the Trial Designed?

Group I: Treatment (daratumumab, bortezomib, dexamethasone, ixazomib) Experimental Treatment 5 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

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

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier