BridgeMD
Iberdomide Manteinance Versus Lenalidomide Manteinance Therapy Following Autologous Stem Cell Transplant in Participants with NDMM
EU CTIS ID: 2022-501515-14-00
What this study is testing
To compare the efficacy of iberdomide to that of lenalidomide in participants with NDMM after ASCT, as measured by PFS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At the time of diagnosis: Participants with confirmed diagnosis of symptomatic MM, defined as monoclonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy-proven plasmacytoma and documented MM satisfying at least 1 of the myeloma-defining events as detailed in the IMWG criteria for the diagnosis of myeloma.
- At enrollment: Eastern Cooperative Oncology Group performance status performance status score of 0, 1, or 2. Participant has received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory compound (IMiD) with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide and dexamethasone and followed by a single or tandem ASCT. Post-stem cell transplant consolidation is permitted. Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction who achieved at least a partial response after ASCT with or without consolidation, according to IMWG 2016 criteria.
- For participants who have not received consolidation therapy, the participant must be within 120 days of the last transplant at the time of randomization.
- For participants treated with consolidation therapy, the participant must be within 30-60 days of the last dose of consolidation therapy at the time of randomization and within 180 days of the last transplant at the time of randomization.
You likely can't join if
- Participant has progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT or is not responsive to primary therapy.
- Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities (POEMS syndrome); or Waldenstrom’s macroglobulinemia.
- Participant has smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- Participant has known central nervous system/meningeal involvement of MM.
- Participant has any of the following laboratory test result abnormalities: absolute neutrophil count < 1,000/μL; Platelet count: < 75,000/μL; Hemoglobin < 8 g/dL (<4.9 mmol/L; Creatinine clearance < 30 mL/min or requiring dialysis; Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L); Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal (ULN) or serum total bilirubin > 1.5 × ULN.
- Peripheral neuropathy of Grade ≥ 2.
See the full eligibility criteria
Who can join
- At the time of diagnosis: Participants with confirmed diagnosis of symptomatic MM, defined as monoclonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy-proven plasmacytoma and documented MM satisfying at least 1 of the myeloma-defining events as detailed in the IMWG criteria for the diagnosis of myeloma.
- At enrollment: Eastern Cooperative Oncology Group performance status performance status score of 0, 1, or 2. Participant has received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory compound (IMiD) with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide and dexamethasone and followed by a single or tandem ASCT. Post-stem cell transplant consolidation is permitted. Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction who achieved at least a partial response after ASCT with or without consolidation, according to IMWG 2016 criteria.
- For participants who have not received consolidation therapy, the participant must be within 120 days of the last transplant at the time of randomization.
- For participants treated with consolidation therapy, the participant must be within 30-60 days of the last dose of consolidation therapy at the time of randomization and within 180 days of the last transplant at the time of randomization.
What rules you out
- Participant has progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT or is not responsive to primary therapy.
- Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities (POEMS syndrome); or Waldenstrom’s macroglobulinemia.
- Participant has smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- Participant has known central nervous system/meningeal involvement of MM.
- Participant has any of the following laboratory test result abnormalities: absolute neutrophil count < 1,000/μL; Platelet count: < 75,000/μL; Hemoglobin < 8 g/dL (<4.9 mmol/L; Creatinine clearance < 30 mL/min or requiring dialysis; Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L); Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal (ULN) or serum total bilirubin > 1.5 × ULN.
- Peripheral neuropathy of Grade ≥ 2.
- Received any prior B-cell maturation antigen directed therapy.
- Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells).
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Switzerland
- Chile
- Canada
- Taiwan
- Colombia
- Singapore
- Israel
- India
- Australia
- Mexico
- Turkey
- Japan
- United Kingdom
- Brazil
- Korea, Republic of
- Hong Kong
- China
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Switzerland; Chile; Canada; Taiwan; Colombia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.