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Proteasome Inhibitor

Carfilzomib + Lenalidomide + Dexamethasone with Stem Cell Transplant for Multiple Myeloma

Phase 2

Waitlist Available

Led By Andrzej Jakubowiak

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Newly diagnosed, myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

Waldenstrom's macroglobulinemia or immunoglobin (Ig)M myeloma

Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 60 Other Conditions

Summary

This trial is studying how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who can follow the study plan, including birth control and testing. They must have certain blood cell counts, organ function, and agree to not get pregnant or father a child. People with recent major surgery, other cancers within 3 years (except some skin cancers), heart issues, uncontrolled diabetes or hypertension, active infections, HIV or hepatitis cannot join.

What is being tested?

The trial tests carfilzomib, lenalidomide & dexamethasone before/after stem cell transplant in treating new multiple myeloma patients. Carfilzomib blocks enzymes cancer cells need; lenalidomide stimulates the immune system; dexamethasone kills or stops cancer cells from dividing.

What are the potential side effects?

Possible side effects include weakened immune system leading to infections; blood clots; nerve damage causing pain/numbness; allergic reactions to drugs used; fatigue and gastrointestinal issues like nausea/vomiting. Organ-specific inflammation may also occur.

Eligibility Criteria

Inclusion Criteria

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

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I have been newly diagnosed with myeloma and need chemotherapy.

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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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I have Waldenstrom's macroglobulinemia or IgM myeloma.

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I do not have severe nerve pain or damage.

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My multiple myeloma shows low or no protein markers before treatment.

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I have POEMS syndrome.

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I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.

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

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My blood pressure or diabetes is not well-managed.

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I have not needed antibiotics or antivirals for an infection in the last two weeks.

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I am HIV positive.

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I cannot take certain medications like aspirin or warfarin due to allergies or past reactions.

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I cannot undergo certain hydration treatments due to existing heart, lung, or kidney conditions.

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I have or might have amyloidosis in an organ.

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I need procedures to remove excess fluid from my chest or abdomen.

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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 cannot afford or my insurance does not cover lenalidomide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Percentage of Patients Achieving sCR

Secondary study objectives

Duration of Response

Overall Response Rate, Defined as at Least a Partial Response to Therapy (> PR), at Least Very Good Partial Response (VGPR) and at Least Near Complete Response (nCR) Rate

Percentage of Participants With Overall Survival (OS)

+2 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.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dexamethasone, carfilzomib, lenalidomide)Experimental Treatment5 Interventions

INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.. TRANSPLANT: Patients undergo autologous stem cell transplant. CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Carfilzomib

FDA approved

Lenalidomide

FDA approved

autologous hematopoietic stem cell transplantation

2003