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Proteasome Inhibitor

Daratumumab + Bortezomib/Dexamethasone & Ixazomib for Multiple Myeloma

Phase 2

Waitlist Available

Led By Hans C Lee

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have achieved a partial response or better to at least one prior line of therapy

Subjects must have histologically confirmed diagnosis of multiple myeloma

Must not have

Subjects with specific medical history and conditions including chronic obstructive pulmonary disease, residual toxicities from prior therapy, recent major surgery, central nervous system involvement of myeloma, uncontrolled intercurrent illness, cardiac conditions, gastrointestinal tract disease, viral infections, other malignancies, lactation or pregnancy, and other specific conditions

Subjects planning to undergo SCT prior to PD on this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for patients with multiple myeloma that has come back or does not respond to treatment. The treatment consists of two drugs given with dexamethasone, a chemotherapy drug. The trial will test how well the treatment works.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related reactions from monoclonal antibodies like daratumumab, chemotherapy effects such as fatigue and digestive issues from dexamethasone, and nerve damage or blood disorders from bortezomib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition improved after previous cancer treatment.

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I have been diagnosed with multiple myeloma through a biopsy.

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

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My condition worsened after the last treatment.

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I am following the required contraceptive measures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe lung disease, recent major surgery, heart issues, or other serious health conditions.

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I plan to have a stem cell transplant before my disease progresses in this study.

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My condition did not improve with bortezomib or carfilzomib treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2000

Dexamethasone

2007

Completed Phase 4

~2650