Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04270175|
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : June 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Amyloid AL Amyloidosis Refractory AL Amyloidosis||Drug: Daratumumab Drug: Pomalidomide Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab|
|Actual Study Start Date :||April 14, 2021|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2025|
(4mg orally) on days 1-21 of a 28-day cycle
Given as 1800mg via injection
Given as 4mg oral capsule
Given as 20mg or 40 mg IV and 20mg or 40mg oral capsule.
- Percentage of Participants With Overall Complete Hematologic Response [ Time Frame: Approximately 3 years ]Overall complete hematologic response rate will be defined as percentage of participants who achieve Complete Hematologic Response
- Median estimate of months that participants have progression free survival [ Time Frame: Approximately 5 years ]Median estimate calculated using the Kaplan-Meier methodology
- Median number of months of participant's overall survival [ Time Frame: Approximately 8 years ]Overall survival (OS) is measured from the date of enrollment to the date of the participant's death
- Time to Complete Hematologic Response [ Time Frame: Approximately 3 years ]Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for hematologic complete response.
- Time to Hematologic progression [ Time Frame: Approximately 5 years ]Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for hematologic progression
- Time until next treatment therapy [ Time Frame: Approximately 5 years ]Measured in months from the date of enrollment to the start date of subsequent treatment for AL amyloidosis
- Percentage of participants for Organ response [ Time Frame: Approximately 5 years ]Organ response rate (OrRR) for kidney and cardiac is defined as the proportion of baseline organ involved participants who achieve organ response in each corresponding organ. Organ response defined for cardiac: N-terminal brain pronatriuretic peptide (NT-proBNP) response (> 30% and > 300 nanogram per liter [ng/L] decrease in participants with baseline NT-proBNP >= 650 ng/L) or New York Heart Association (NYHA) class response (>= 2 class decrease in participants with baseline NYHA class 3 or 4); for kidney: decrease in proteinuria by >=30% or below 0.5 grams /24 hours without renal progression.
- Duration of Very Good Partial Response (VGPR) or better hematologic response rates [ Time Frame: Approximately 3 years ]Duration of hematologic VGPR or better response is defined as the time between the date of initial documentation of hematologic VGPR or better response to the date of first documented evidence of hematologic progressive disease.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270175
|Contact: Kathleen P Research Nurse Coordinator, RNfirstname.lastname@example.org|
|United States, California|
|Palo Alto, California, United States, 94304|
|Contact: Michaela Liedtke, MD email@example.com|
|Principal Investigator: Michaela Liedtke, MD|
|United States, Massachusetts|
|Boston University Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Vaishali Sanchorawala, MD Vaishali.Sanchorawala@bmc.org|
|Principal Investigator: Vaishali Sanchorawala, MD|
|United States, New York|
|Weill Cornell Medicine - Multiple Myeloma Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Research Nurse Coordinator 646-962-6500 firstname.lastname@example.org|
|Contact: Research Nurse Coordinator (646) 962-6500 email@example.com|
|Principal Investigator: Cara Rosenbaum, MD|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Anita D'Souza, MD firstname.lastname@example.org|
|Principal Investigator: Anita D'Souza, MD|
|Principal Investigator:||Cara Rosenbaum, MD||Weill Medical College of Cornell University|
|Responsible Party:||Weill Medical College of Cornell University|
|Other Study ID Numbers:||
|First Posted:||February 17, 2020 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Immunoglobulin Light-chain Amyloidosis
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Angiogenesis Modulating Agents