Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
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.
- AL Amyloidosis
- Refractory AL Amyloidosis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Diagnosis of primary AL amyloidosis of tissue - Relapsed and/or refractory AL amyloidosis - 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). - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN. - Calculated creatinine clearance ≥ 30 mL/min (see Appendix 11.2).
- Non-AL amyloidosis - Clinically overt myeloma - Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies or pomalidomide. - 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 enrollment. - Radiotherapy within 14 days before enrollment. - Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, see Appendix 11.7), or use of Ginkgo biloba or St. John's wort. - Positive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C - 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.
- Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|Pomalidomide: (4mg orally) on days 1-21 of a 28-day cycle Dexamethasone: 20mg IV as premedication on days 1, 8, 15, and 22 20mg orally the day after daratumumab dosing for cycles 1-2 of induction 40mg IV as premedication on days 1 and 15 on daratumumab treatment days 40mg orally on non-daratumumab days (8 and 15) for cycles 3-6 20mg on day 1 of every cycle as premedication on daratumumab dosing day 1 in maintenance cycles (cycles 7 and beyond) If you are a subject age 70 and older, the dexamethasone dosing will be reduced by 50% at the time of induction. Daratumumab: 1800mg sub-cutaneously weekly x8 weeks 1800mg sub-cutaneously every 2 weeks during induction (cycles 3-6) 1800mg sub-cutaneously every 4 weeks cycles 7 and beyond||
- Weill Medical College of Cornell University
Study ContactKathleen P Research Nurse Coordinator, RN