Multiple Myeloma Clinical Trial

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

Summary

This is a single-center single-arm phase 2 study in which patients will receive daratumumab in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity, whichever comes first. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone (ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed Multiple Myeloma
Relapsed and/or refractory myeloma defined as follows: Relapse or progressive disease after at least one previous line of therapy which must include prior daratumumab. At least 8 doses of daratumumab in a previous line must be administered either as monotherapy or in combination with a daratumumab-free interval of ≥3 months AND patient may be daratumumab refractory defined as less than a partial remission (PR) achieved on prior daratumumab-based therapy or have exhibited progression within 60 days of receiving daratumumab. If previous therapy was autologous stem cell transplant (SCT), over 3 months must have elapsed after SCT.
Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
Females of childbearing potential(FCBP) must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of prescribing pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Able to take aspirin daily
Life expectancy must be greater than 3 months.
Be able to voluntarily sign and understand written informed consent.
Absolute neutrophil count (ANC) ≥750 cells/mm3 (.75 x 109/L)
Platelets count ≥ 50,000/mm3 (50 x 109/L)
Serum SGOT/AST ≤ 2.0 x upper limits of normal
Serum SGPT/ALT <3.0 x upper limits of normal
Serum creatinine ≤ 2.5 x upper limits of normal
Serum total bilirubin ≤ 1.5 x upper limits of normal
All participants must be registered into the mandatory POMALYST REMS™ program and be willing and able to comply with the requirements of the POMALYST REMS™ program.

Exclusion Criteria:

Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies or pomalidomide
New York Heart Association (NYHA) Class III or IV heart failure, unstable cardiac arrhythmia, or unstable angina
Myocardial infarction within the past 6 months
Severe obstructive airway disease
Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy
Major surgery within 14 days before enrollment
Radiotherapy within 14 days before enrollment (if area involved is small than within 7 days)
Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
Seropositive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
Patient has greater than Grade 3 peripheral neuropathy, or Grade 2 pain
Participation in other clinical trials within 30 days
History of thromboembolic event within the past 6 months prior to enrollment

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT04302324

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

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There is 1 Location for this study

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Weill Cornell Medicine - Multiple Myeloma Center
New York New York, 10065, United States More Info
Research Nurse, RN
Contact
646-962-6500
Cara Rosenbaum, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT04302324

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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