Phase 2 Trial of Iberdomide + SC Daratumumab as Post-Autologous Stem Cell Transplant Maintenance Therapy in Multiple Myeloma
Study of Investigational Medication for Multiple Myeloma
Malini Surapaneni
Primary Investigator
Brief description of study
Multicenter phase 2 trial utilizing oral iberdomide and subcutaneous daratumumab for up to 24 months in patients with multiple myeloma who are not minimal residual disease negative after induction therapy and autologous stem cell transplant. Research study involving the combination of daratumumab SC and iberdomide with participants who have multiple myeloma which is still detectable after induction therapy (the first line of treatment for disease) and then an autologous stem cell transplant (ASCT), which uses healthy blood stem cells from their own body to replace their diseased or damaged bone marrow after the use of high dose chemotherapy.
Detailed description of study
This is a single-stage Phase 2 trial evaluating IBER+DARA in 55 MRD-evaluable patients who have
previously had DARA-containing induction therapy followed by ASCT. Patients will be treated for a
maximum of 24 months (26 four-week cycles), and MRD status will be assessed after 6, 12, 24 months,
and end of therapy
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Multiple Myeloma, Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria:
1. Multiple Myeloma patients who have received prior DARA-containing
induction therapy and have attained at least a partial response.
2. Patients who have completed Autologous Stem Cell Transplant (ASCT)
90-150 days prior to registration, without any post-ASCT therapy and
without post-ASCT disease progression (according to IMWG criteria)
3. Patients who are Minimal Residual Disease positive (MRD(+)) as
measured by the ClonoSEQ assay using a sensitivity of 10-5
The purpose of this study is to investigate the use of an investigational medication as a maintenance therapy for patients with multiple myeloma after they have undergone an autologous stem cell transplant. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. This study aims to understand how effective the treatment is in achieving minimal residual disease (MRD) negative responses, which indicates a very low level of cancer cells.
Participants in this study will receive the investigational medication through subcutaneous injections. The study will monitor the frequency of MRD negative responses and assess the safety of the treatment. Additionally, the study will evaluate patients' quality of life using specific surveys at the start of each treatment cycle.
- Who can participate: The study is looking for participants who have undergone an autologous stem cell transplant for multiple myeloma. Specific eligibility criteria were not provided.
- Study details: Participants will receive an investigational medication through subcutaneous injections as part of the maintenance therapy. The study will also involve completing quality of life surveys at the beginning of each treatment cycle.
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