CO43923 Master Protocol: A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients with Multiple Myeloma CO43923 Substudy 1: A Non-Interventional Study to Collect Patient-Level Data in Patients with Multiple Myeloma CO43923 Substudy 2 Cevos + Len Treatment: A Phase Ib, Single Arm, Open-Label 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 Phase Ib, Single Arm, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Combination with Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I-II
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Leucemia mieloide aguda, Mieloma Múltiple y otras gammapatías, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Linfoma
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Daniel Morillo
FECHA DE APERTURA
Julio, 2022
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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
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
CRITERIOS DE EXCLUSIÓN
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
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
DESCRIPCIÓN
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.
PALABRAS CLAVE
donor lymphocyte infusion, emr, leucemia linfocítica crónica (llc / cll), multiple myeloma, myeloma, stem cell
