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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2021
Main ID:  NCT04270175
Date of registration: 12/02/2020
Prospective Registration: Yes
Primary sponsor: Weill Medical College of Cornell University
Public title: Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
Scientific title: Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
Date of first enrolment: February 2021
Target sample size: 21
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04270175
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Kathleen P Research Nurse Coordinator, RN
Address: 
Telephone: 646-962-6500
Email: kap9111@med.cornell.edu
Affiliation: 
Name:     Cara Rosenbaum, MD
Address: 
Telephone:
Email:
Affiliation:  Weill Cornell Medicine
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
AL Amyloidosis
Amyloid
Refractory AL Amyloidosis
Intervention(s)
Drug: Daratumumab
Drug: Dexamethasone
Drug: Pomalidomide
Primary Outcome(s)
Percentage of Participants With Overall Complete Hematologic Response [Time Frame: Approximately 3 years]
Secondary Outcome(s)
Duration of Very Good Partial Response (VGPR) or better hematologic response rates [Time Frame: Approximately 3 years]
Median estimate of months that participants have progression free survival [Time Frame: Approximately 5 years]
Median number of months of participant's overall survival [Time Frame: Approximately 8 years]
Percentage of participants for Organ response [Time Frame: Approximately 5 years]
Time to Complete Hematologic Response [Time Frame: Approximately 3 years]
Time to Hematologic progression [Time Frame: Approximately 5 years]
Time until next treatment therapy [Time Frame: Approximately 5 years]
Secondary ID(s)
19-12021159
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Janssen Scientific Affairs, LLC
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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