Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab

  • STATUS
    Recruiting
  • End date
    Feb 14, 2025
  • participants needed
    21
  • sponsor
    Weill Medical College of Cornell University
Updated on 14 June 2022
platelet count
combination therapy
measurable disease
dexamethasone
neutrophil count
daratumumab

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.

Details
Condition Amyloid, AL Amyloidosis, Refractory AL Amyloidosis
Treatment Pomalidomide, Dexamethasone, Daratumumab
Clinical Study IdentifierNCT04270175
SponsorWeill Medical College of Cornell University
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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