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

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Trial ID: NCT04270175

Purpose

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.

Official Title

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

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Eligibility


Inclusion Criteria:

   - 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 Criteria:

   - 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.

Intervention(s):

drug: Pomalidomide

drug: Dexamethasone

drug: Daratumumab SC

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Reneth T. Inthasack
650-723-0646

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