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Proteasome Inhibitor

Quadruple Therapy + Stem Cell Transplant for Multiple Myeloma

Phase 2

Waitlist Available

Led By Gunjan Shah, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Cardiac left ventricular ejection fraction of greater than 40%

More than 2 x 10^6 autologous CD34+ cells/kg cryopreserved. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center

Must not have

Plasma cell leukemia (>20% circulating plasma cells) during screening studies

POEMS syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of giving two drugs before and after stem cell transplant.

Who is the study for?

This trial is for adults aged 18-75 with multiple myeloma that has worsened after 1 to 3 treatments. They must have enough healthy stem cells saved, good kidney function, and no severe heart or liver issues. Women who can get pregnant and men must use birth control. People with HIV, uncontrolled illnesses, recent major surgery, CNS myeloma involvement, significant neuropathy or allergic reactions to the drugs are excluded.

What is being tested?

The study tests a combination of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab given before and after an autologous stem cell transplant in patients with relapsed/refractory multiple myeloma. The goal is to see the effects of this regimen on the disease's progression.

What are the potential side effects?

Possible side effects include weakened immune system leading to infections; blood clots; heart problems like high blood pressure; lung complications; liver toxicity; nerve damage causing numbness or pain; digestive issues such as nausea or diarrhea; fatigue and increased risk of second cancers.

Eligibility Criteria

Inclusion Criteria

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

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My heart pumps well, with an ejection fraction over 40%.

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I have over 2 million per kg of my own CD34+ cells stored for transplant.

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I have had only one treatment cycle since my last cancer progression.

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I am mostly able to care for myself and carry out daily activities.

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I am able and willing to sign the consent form.

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My multiple myeloma diagnosis has been confirmed by tests.

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My myeloma has worsened after 1-3 treatments.

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I agree to use birth control methods.

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I am between 18 and 75 years old.

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My kidneys are functioning well enough to clear waste.

Exclusion Criteria

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

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My blood test shows more than 20% plasma cells.

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I have been diagnosed with POEMS syndrome.

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My blood pressure or diabetes is not well-managed.

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

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My condition worsened despite taking daratumumab.

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I do not have severe heart problems like recent heart attacks or very weak heart function.

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I have had moderate to severe asthma or uncontrolled asthma in the last 2 years.

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I have severe nerve pain or discomfort.

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I have had a stem cell transplant from a donor.

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I cannot take certain medications, including antivirals or blood thinners.

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My lung function is less than half of what it should be due to COPD.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My myeloma has affected my central nervous system.

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I have an active hepatitis B or C infection.

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I have experienced severe side effects from carfilzomib or lenalidomide.

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My stomach or intestines can't absorb medicine taken by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

number of patients with complete remission (CR) rate

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: Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab & HCTExperimental Treatment5 Interventions

After receiving four 28-day cycles of Dara-CRd, eligible patients will then undergo HCT with high dose melphalan conditioning. Sixty to ninety days after HCT, patients will receive another 4 cycles of Dara-CRd.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Carfilzomib

2017

Completed Phase 3

~1430