This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone with daratumumab SC (D-ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given as 1800mg via injection
Given as 500mg oral capsule
Given as 4mg oral capsule
Given as 20mg IV and 20mg or 40mg oral tablets
Weill Cornell Medicine - Multiple Myeloma Center
New York, New York, United States
Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy
Very Good Partial Response or better defined as the number of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle.
Time frame: up to end of 8th induction cycle (up to approximately 224 days)
Progression-Free Survival
Progression-Free Survival (PFS) is measured in months from the date of enrollment to the date of disease progression and/or death. Median estimate is calculated using the Kaplan-Meier methodology.
Time frame: Approximately 3 years
Complete Response Rate or Better
The number of participants with a documented Complete Response (CR) or better, per International Myeloma Working Group (IMWG) criteria.
Time frame: Approximately 1 year
Time to Progression
Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for Progressive Disease
Time frame: Approximately 3 years
Time to Next Therapy
Measured in months from the date of enrollment to the start date of subsequent treatment for relapsed/refractory multiple myeloma
Time frame: Approximately 3 years
Duration of Response
Duration of Response (DoR) is defined as the time between the date of initial documentation of best response to the date of first documented evidence of disease progression.
Time frame: Approximately 3 years
Rate of Minimal Residual Disease (MRD) Negativity
Defined as a number of MRD negative participants
Time frame: Approximately 8 months
Rate of Improvement in Response During Maintenance Therapy
Percentage of patients that achieved an improved response during maintenance compared to end of induction.
Time frame: Approximately 3 years
Time to Best Response
Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met criteria for best response per International Myeloma Working Group (IMWG) criteria.
Time frame: Approximately 9.5 months
Overall Response Rate
The number of participants with a documented Overall Response (Partial Response or better), per International Myeloma Working Group (IMWG) criteria.
Time frame: Approximately 1 year
Very Good Partial Response (VGPR) Rate or Better
The number of participants with a documented Very Good Partial Response (VGPR) Rate or better, per International Myeloma Working Group (IMWG) criteria.
Time frame: Approximately 1 year
Overall Survival
Overall Survival (OS) is measured in months from the date of enrollment to the date of the participant's death. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier survival estimates.
Time frame: Approximately 5 years
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