DPd for Amyloidosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot use certain medications like strong CYP3A inducers (e.g., rifampin, carbamazepine) or supplements like Ginkgo biloba or St. John's wort within 14 days before starting the trial.
Is the DPd treatment generally safe for humans?
The combination of daratumumab, pomalidomide, and dexamethasone (DPd) has been studied in various trials and is generally considered to have an acceptable safety profile. Common side effects include neutropenia (low white blood cell count) and fatigue, but these are consistent with the individual drugs used in the treatment. Overall, the treatment has been well tolerated in patients with conditions like amyloidosis and multiple myeloma.12345
How does the DPd drug differ from other treatments for amyloidosis?
The DPd drug, which combines daratumumab, pomalidomide, and dexamethasone, is unique because it leverages the success of these components in treating multiple myeloma to address severe cases of amyloidosis, especially with advanced cardiac involvement. This combination has shown rapid and deep responses, improving symptoms and organ function, making it a promising option for patients who do not respond well to standard treatments.13678
What evidence supports the effectiveness of the drug combination DPd for treating amyloidosis?
Research shows that the combination of daratumumab, pomalidomide, and dexamethasone (DPd) has been effective in treating light-chain amyloidosis, especially in patients with severe symptoms. In one case, a patient with advanced cardiac involvement experienced significant improvement in symptoms and organ function after switching to DPd, suggesting its potential as a promising treatment option.123910
Who Is on the Research Team?
Cara Rosenbaum, MD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for patients with relapsed/refractory light chain amyloidosis who have previously been treated with daratumumab. They should be relatively healthy (performance status 0-2), have normal liver function, stable kidney function, and acceptable blood counts. Patients must not have non-AL amyloidosis, serious infections, significant heart disease, or recent major surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daratumumab, pomalidomide, and dexamethasone (DPd) therapy. Pomalidomide is administered orally on days 1-21 of a 28-day cycle. Dexamethasone is given as premedication and on specific days depending on the cycle. Daratumumab is administered subcutaneously weekly for 8 weeks, then every 2 weeks during induction, and every 4 weeks during maintenance.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on hematologic and organ response rates.
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- Dexamethasone
- Pomalidomide
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University