Status:
ACTIVE_NOT_RECRUITING
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Amyloid
AL Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04270175
Start Date
April 14 2021
End Date
January 1 2028
Last Update
October 29 2025
Active Locations (4)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Boston University Medical Center
Boston, Massachusetts, United States, 02118
3
Weill Cornell Medicine - Multiple Myeloma Center
New York, New York, United States, 10065
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226