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Proteasome Inhibitor

Daratumumab + KRd for Multiple Myeloma

Phase 2

Waitlist Available

Led By Saad Usmani, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 28 days prior to day 1 of treatment

FCBP must be willing to use a highly effective contraceptive method plus a second contraceptive method

Must not have

Active and/or progressive additional malignancy

Exposure to any investigational drug or invasive investigational medical device within 4 weeks or 5 pharmacokinetic half-lives prior to day 1 of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat Multiple Myeloma, which is a cancer of the plasma cells. The drugs work together to attack the cancer cells and destroy them. This new combination has shown to be effective in subjects with MM in preliminary trials.

Who is the study for?

This trial is for adults over 18 with newly diagnosed multiple myeloma. Participants must have good organ function, not be pregnant or breastfeeding, agree to use effective contraception methods, and cannot have had more than one prior treatment cycle for MM. They should not have severe lung conditions, recent major surgery, other active cancers or certain infections.

What is being tested?

The study tests a combination of daratumumab with carfilzomib, lenalidomide and dexamethasone in new multiple myeloma cases. Daratumumab is an artificial protein that targets cancer cells and activates the immune system to fight them when combined with these medications.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's activation such as flu-like symptoms, fatigue, nausea; possible blood disorders; increased risk of infections due to lowered immunity; and specific drug-related reactions which will vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I have been active and mostly self-sufficient in the last 28 days.

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I am committed to using two effective birth control methods.

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I am 18 years old or older.

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I have been newly diagnosed with multiple myeloma.

Exclusion Criteria

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

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I have another cancer that is growing or spreading.

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I haven't used any experimental drugs or devices within the last 4 weeks.

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I have had a stroke with lasting effects.

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I have not had major surgery in the last 2 weeks.

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I do not have any unmanaged serious illnesses.

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I am currently on medication for an infection.

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My lung function is less than half of what is expected for someone my age and size.

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I have not had targeted radiation therapy in the last 14 days.

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

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My multiple myeloma does not produce detectable levels of M protein.

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I have been treated with daratumumab or similar medications before.

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I am over 70 and considered too frail for a transplant.

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I have been diagnosed with POEMS syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks for reporting.