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Monoclonal Antibodies

Quad Regimen for Multiple Myeloma

Phase 2

Waitlist Available

Led By Suzanne George, MD

Research Sponsored by Alliance Foundation Trials, LLC.

Eligibility Criteria Checklist

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

Must have

Subject must have documented multiple myeloma with specific criteria for clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma

Females of reproductive potential must agree to adhere to the scheduled pregnancy testing as required in the Revlimid REMS program

Must not have

Received an investigational drug or used an invasive investigational medical device within a specific time frame prior to initial dosing or currently enrolled in an interventional investigational study

Contraindications to required protocol prophylaxis for deep vein thrombosis and pulmonary embolism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess if adding ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab will impact progression free survival.

Who is the study for?

This trial is for adults over 18 with newly diagnosed Multiple Myeloma who can't have a stem cell transplant. They must not be pregnant, planning to become pregnant, or breastfeeding and agree to use two birth control methods if applicable. Participants need an ECOG score of 0-2 and meet specific health criteria without severe allergies or recent treatments that could interfere.

What is being tested?

The study tests whether adding ixazomib and daratumumab to lenalidomide maintenance therapy after initial treatment with these drugs plus dexamethasone improves patient outcomes. It's randomized: one group gets the full combo followed by just lenalidomide; the other continues all three drugs as maintenance.

What are the potential side effects?

Possible side effects include blood clots, nerve damage (neuropathy), infections due to low white blood cell counts, diarrhea, constipation, fatigue, rash, muscle cramps, fever with chills and breathing difficulties from Daratumumab infusions.

Eligibility Criteria

Inclusion Criteria

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

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I have confirmed multiple myeloma with specific test results.

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I agree to follow the pregnancy testing schedule as required.

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I am 18 years old or older.

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

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I have a new diagnosis and am not eligible for high-dose chemotherapy with stem cell transplant.

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My condition has caused damage to my organs or shown specific myeloma signs.

Exclusion Criteria

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

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I have not used any experimental drugs or devices recently.

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I cannot take certain medications to prevent blood clots.

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I do not have any uncontrolled medical or mental health conditions.

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I do not have any serious heart conditions.

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I have had Waldenström's disease or conditions with IgM protein without bone damage.

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I show signs of my multiple myeloma affecting the lining of my brain recently.

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I haven't taken strong CYP3A inducers or St. John's wort recently.

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I have had severe nerve pain or tingling in the past few months.

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I have never had plasma cell leukemia or POEMS syndrome.

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I haven't had major surgery recently or planned soon.

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I have been diagnosed with primary AL amyloidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Impact of Study Treatment on Progression Free Survival (PFS)

Secondary study objectives

Alliance Geriatric Assessment with IMWG Fragility Score

Minimal Residual Disease (MRD)

Overall Response Rate (ORR)

+6 more

Other study objectives

Changes in Body Composition After Induction Therapy

Circulating MM cells and circulating DNA through DNA sequencing

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Lenalidomide, Ixazomib, Daratumumab, and DexamethasoneExperimental Treatment4 Interventions

12 cycles of lenalidomide, ixazomib, dexamethasone, and daratumumab followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 year maintenance therapy.

Group II: LenalidomideExperimental Treatment4 Interventions

12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3510

Daratumumab Injection

2020

Completed Phase 2

~20