Chemotherapy + Stem Cell Transplant for Amyloidosis
Trial Summary
The trial protocol does not specify if you need to stop taking your current medications. However, you may continue taking chronic corticosteroids if they are for conditions other than AL amyloidosis or myeloma. It's best to discuss your specific medications with the study team.
Research shows that Daratumumab, when used alone or with other drugs, significantly improves blood and organ responses in patients with AL amyloidosis. It has been effective in both newly diagnosed and previously treated patients, with studies showing high rates of response and good tolerability.
12345Daratumumab, when used in combination with other chemotherapy drugs for treating amyloidosis, has been shown to have a tolerable safety profile with no significant treatment-related adverse events reported in multiple studies. It is generally well tolerated, and no new safety concerns were identified compared to its use in other conditions.
12367Daratumumab, when combined with other drugs like bortezomib, cyclophosphamide, and dexamethasone, offers a unique treatment for amyloidosis by targeting a specific protein (CD38) on cells, leading to improved blood and organ responses. This combination is particularly effective for patients who are newly diagnosed or have relapsed, providing a promising option with a good safety profile compared to traditional treatments.
12368Eligibility Criteria
This trial is for adults with newly diagnosed AL amyloidosis, confirmed by specific tests like urine and serum immunofixation electrophoresis, bone marrow analysis, and biopsy. Participants must have a certain level of light chain difference in their blood and can have had up to one cycle of prior therapy. They should be able to perform daily activities on their own or with some effort (ECOG score 0-2) but may be less mobile due to neuropathy.Inclusion Criteria
Participant Groups
- 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