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Monoclonal Antibodies

Quad Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Caitlin Costello, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of Multiple Myeloma having received 1 and 3 prior lines of treatment

All pts must have received prior lenalidomide therapy and been determined to be relapsed and/or refractory.

Must not have

Patients who are refractory to pomalidom

Prior daratumumab or ixazomib use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test how effective the Daratumumab, Ixazomib, Pomalidomide and Dexamethasone combination is for Multiple Myeloma patients.

Who is the study for?

This trial is for adults with Multiple Myeloma who've had 1-3 prior treatments but haven't used Daratumumab or Ixazomib before. They must not be pregnant, agree to birth control measures, and join the POMALYST REMS program. Participants should have a life expectancy over 3 months, an ECOG status of 0-2, and adequate organ function.

What is being tested?

The study tests a combination therapy using Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in patients with relapsed/refractory Multiple Myeloma. It aims to evaluate the overall response rate to this salvage therapy regimen.

What are the potential side effects?

Potential side effects include blood clots requiring aspirin or anticoagulants; risk of infections; possible allergic reactions; liver issues due to hepatic function requirements; fatigue from dexamethasone; and gastrointestinal problems.

Eligibility Criteria

Inclusion Criteria

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

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I have Multiple Myeloma and have been treated 1 to 3 times before.

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I have taken lenalidomide before and my condition worsened or didn't improve.

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My white blood cell and hemoglobin levels are within the required range.

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I agree to follow the pregnancy testing schedule as required.

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I have not worsened while on pomalidomide.

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My cancer has returned or is not responding to treatment.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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My condition did not improve after taking pomalidomide.

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I have previously used daratumumab or ixazomib.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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

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I am HIV positive or suspected to be.

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My multiple myeloma has spread to my brain or spinal cord.

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I have no stomach or intestine problems that affect how I absorb pills.

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I have not had major surgery in the last 3 weeks.

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I have an active hepatitis infection.

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I have or might have amyloidosis affecting an organ.

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I am allergic to some specific cancer drugs or their ingredients.

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I am not pregnant or breastfeeding.

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I have been diagnosed with moderate or severe asthma in the last 2 years.

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My multiple myeloma does not produce high levels of antibodies.

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I have severe COPD with less than half the normal lung function.

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I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Overall Response Rate

Secondary study objectives

Clinical benefit rate

Minimal Residual Disease (MRD)

Overall survival (OS)

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: ixazomib, daratumumab, pomalidomide and dexamethasoneExperimental Treatment4 Interventions

Daratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3510

Pomalidomide

2011

Completed Phase 2

~1020