DARZALEX FASPRO® for Peripheral Neuropathy
(Dara-MGUS Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing an injectable medication called DARZALEX FASPRO® in patients with MGUS who have nerve damage. The goal is to see if this treatment can improve their nerve-related symptoms. The medication works by helping the immune system target abnormal cells and improving absorption of the drug.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications for conditions like diabetes, vitamin deficiencies, or chronic alcohol consumption, you may be excluded from the trial.
Eligibility Criteria
Adults with MGUS-related peripheral neuropathy, who have certain levels of nerve damage and disability, can join. They must have good bone marrow and liver function, use effective birth control, and not be pregnant or breastfeeding. People with prior daratumumab exposure, HIV, hepatitis B/C, other cancers like multiple myeloma or serious medical conditions that could risk safety are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Daratumumab (Monoclonal Antibodies)
Daratumumab is already approved in European Union, United States for the following indications:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone