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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Daratumumab; Dexamethasone; Dexamethasone acetate; Pomalidomide; Thalidomide

Criteria

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.