BridgeMD
CO43923 Master Protocol: A Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients with Multiple Myeloma CO43923 Substudy 1: A Study to Collect Patient-Level Data in Patients with Multiple Myeloma CO43923 Substudy 2 Cevos + Len Treatment: A Study Evaluating the Safety and Efficacy of Cevostamab in Combination with Lenalidomide in Patients with Cytogenetic High-Risk Features Receiving Maintenance Treatment After First Response from Multiple Myeloma Post-Stem Cell Transplant CO43923 Substudy 4 Cevostamab+ Iberdomide Treatment: A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Combination with Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
EU CTIS ID: 2023-504484-16-00
What this study is testing
CO43923 Master Protocol: - Stage 1: To evaluate the safety of the study treatment, including evaluation of the tolerability of the dosing schedules and doses - Stage 1: To characterize maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) when a dose-finding phase is used - Stage 2: To evaluate the efficacy of the study treatment based on objective response rate (ORR), rate of complete response (CR) or stringent complete response (sCR), rate of very good partial response (VGPR), progression-free survival (PFS) and overall survival (OS) CO43923 Substudy 1: To describe patient and disease characteristics and treatment patterns from initial diagnosis of patients with first-line and later lines of therapy in relapsed or refractory multiple myeloma (R/R MM) CO43923 Substudy 2 Cevos + Len Treatment: To evaluate the safety of cevostamab in combination with lenalidomide (Cevos + Len) as a maintenance treatment in patients with MM after autologous stem cell transplant (SCT) following first-line treatment CO43923 Substudy 4 Cevostamab+ Iberdomide Treatment: To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in combination with iberdomide (Cevostamab + Iberdomide) in patients with R/R MM.
- Phase I and Phase II (Integrated)- Other
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
- CO43923 Master Protocol: Diagnosed with multiple myeloma (MM) per International Myeloma Working Group (IMWG) criteria
- CO43923 Master Protocol: Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- CO43923 Substudy 1: A current or past diagnosis of MM in the first line or later setting, including maintenance therapy
- CO43923 Substudy 2 Cevos + Len Treatment: Completion of planned induction therapy and achievement of at least a partial response (PR)
- CO43923 Substudy 4 Cevostamab+ Iberdomide Treatment: Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R/R MM for whom no suitable SOC therapy options are available
You likely can't join if
- CO43923 Master Protocol: History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death
- CO43923 Master Protocol: History of confirmed progressive multifocal leukoencephalopathy
- CO43923 Master Protocol: Known history of HIV seropositivity
- CO43923 Substudy 2 Cevos + Len Treatment: Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs
- CO43923 Substudy 4 Cevostamab+ Iberdomide Treatment: Treatment with systemic immunosuppressive medications including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to starting pre-phase
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Australia
- Korea, Republic of
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Australia; Korea, Republic of. 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.