Phase II Study of Daratumumab, Clarithromycin, Pomalidomide, and Dexamethasone for Multiple Myeloma Patients Previously Treated with Daratumumab
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT04302324
This clinical trial is testing a combination of drugs, including daratumumab, clarithromycin, pomalidomide, and dexamethasone, to see if they can improve treatment outcomes for patients with multiple myeloma who have previously been treated with daratumumab.
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Program Overview
This study aims to find out if a combination of four drugs—daratumumab, clarithromycin, pomalidomide, and dexamethasone—can help patients with multiple myeloma who have already been treated with daratumumab. The trial will look at whether this combination can lead to better responses in patients whose cancer has returned or not responded to previous treatments.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma.
- Cancer has returned or not responded after at least one previous treatment, including daratumumab.
- Must have received at least 8 doses of daratumumab in the past, with a break of at least 3 months between treatments.
- Measurable disease based on specific medical tests.
- Women who can become pregnant must have a negative pregnancy test and agree to use two forms of birth control.
- General health status must be good, with a performance score of 0, 1, or 2.
- Able to take aspirin daily.
- Life expectancy of more than 3 months.
- Willing to sign informed consent.
- Meet specific blood count and organ function requirements.
- Must be registered in the POMALYST REMS program and comply with its requirements.
Exclusion Criteria
- Previous treatment with non-daratumumab anti-CD38 antibodies or pomalidomide, unless a good response was achieved.
- Severe heart problems or recent heart attack.
- Severe lung disease.
- Planned high-dose chemotherapy or stem cell transplant soon after starting treatment.
- Pregnant or breastfeeding women.
- Not fully recovered from previous chemotherapy.
- Recent major surgery or radiation therapy.
- Recent use of certain medications or supplements.
- Positive for HIV, hepatitis B, or hepatitis C.
- Serious medical or psychiatric conditions that could interfere with the study.
- Allergies to study medications.
- Recent diagnosis or treatment for another cancer, unless fully treated.
- Severe nerve damage or pain.
- Participation in another clinical trial within the last 30 days.
- Recent history of blood clots.
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