Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis… (NCT04270175) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
United States15 participantsStarted 2021-04-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of primary AL amyloidosis of tissue
* Relapsed and/or refractory AL amyloidosis
* Has received daratumumab or Faspro in any prior line of therapy
* Prior pomalidomide exposure allowed if ≥ PR achieved and no disease progression occurred within 60 days of last dose received
* Measurable disease
* Able to give voluntary written consent
* Eastern Cooperative Oncology Group performance status and/or other performance status 0, 1, or 2.
* Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3.
* Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN) (Total bilirubin ≥ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
* eGFR ≥ 20 mL/min/1.73 m2 (as calculated by Modified Diet in Renal Disease (MDRD) formula)
Exclusion Criteria:
* Non-AL amyloidosis
* Clinically overt myeloma
* Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies.
* Clinically significant cardiac disease
* Severe obstructive airway disease
* Female patients who are lactating or have a positive serum pregnancy test during the screening period
* Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment.
* Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
* Major surgery within 14 days before enroll…
What they're measuring
1
Percentage of Participants With Overall Complete Hematologic Response
Timeframe: Follow-up for up to 1 year
Trial details
NCT IDNCT04270175
SponsorWeill Medical College of Cornell University