This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Given as 1800mg via injection
Given as 4mg oral capsule
Given as 20mg or 40 mg IV and 20mg or 40mg oral tablet.
Stanford University
Palo Alto, California, United States
Boston University Medical Center
Boston, Massachusetts, United States
Weill Cornell Medicine - Multiple Myeloma Center
New York, New York, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Percentage of Participants With Overall Complete Hematologic Response
Overall complete hematologic response rate will be defined as percentage of participants who achieve Complete Hematologic Response
Time frame: Follow-up for up to 1 year
Duration of Very Good Partial Response (VGPR) or better hematologic response rates
Duration of hematologic VGPR or better response is defined as the time between the date of initial documentation of hematologic VGPR or better response to the date of first documented evidence of hematologic progressive disease.
Time frame: Follow-up for up to 5 years
Low-dFLC Partial Response Rate (applicable to low-dFLC pt group)
Percentage of participants who achieve a low-dFLC partial hematologic response rate and met criteria at screening for low-dFLC response assessment
Time frame: Follow-up for up to 1 year
Percentage of participants with an Organ Response
Organ response rate (OrRR) for kidney and cardiac is defined as the proportion of baseline organ involved participants who achieve organ response in each corresponding organ. Organ response defined for cardiac: N-terminal brain pronatriuretic peptide (NT-proBNP) response (\> 30% and \> 300 nanogram per liter \[ng/L\] decrease in participants with baseline NT-proBNP \>= 650 ng/L) or New York Heart Association (NYHA) class response (\>= 2 class decrease in participants with baseline NYHA class 3 or 4); for kidney: decrease in proteinuria by \>=30% or below 0.5 grams /24 hours without renal progression.
Time frame: Follow-up for up to 3 years
Median estimate of months that participants have Progression Free Survival
Median estimate calculated using the Kaplan-Meier methodology
Time frame: Follow-up for up to 5 years
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Median number of months of participant's Overall Survival
Overall survival (OS) is measured from the date of enrollment to the date of the participant's death
Time frame: Follow-up for up to 5 years
Time to Complete Hematologic Response
Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for hematologic complete response.
Time frame: Follow-up for up to 1 year
Time to Hematologic Progression
Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for hematologic progression
Time frame: Follow-up for up to 5 years
Time until Next Treatment Therapy
Measured in months from the date of enrollment to the start date of subsequent treatment for AL amyloidosis
Time frame: Follow-up for up to 5 years