Multiple Myeloma Clinical Trial

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

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

21

Study ID:

NCT04270175

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

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There are 4 Locations for this study

See Locations Near You

Stanford University
Palo Alto California, 94304, United States More Info
Michaela Liedtke, MD
Contact
[email protected]
Michaela Liedtke, MD
Principal Investigator
Boston University Medical Center
Boston Massachusetts, 02118, United States More Info
Vaishali Sanchorawala, MD
Contact
[email protected]
Vaishali Sanchorawala, MD
Principal Investigator
Weill Cornell Medicine - Multiple Myeloma Center
New York New York, 10065, United States More Info
Research Nurse Coordinator
Contact
646-962-6500
[email protected]
Research Nurse Coordinator
Contact
(646) 962-6500
[email protected]
Cara Rosenbaum, MD
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Anita D'Souza, MD
Contact
[email protected]
Anita D'Souza, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

21

Study ID:

NCT04270175

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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