A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination with Elranatamab in Participants with Relapsed and/or Refractory Multiple Myeloma
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I-II
PATOLOGÍA
Mieloma Múltiple y otras gammapatías
FECHA DE APERTURA
Ocutbre, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Signed Written Informed Consent
Participant with a history of RRMM who received 2 to 4 prior lines of anti-myeloma therapy.
Participants must have measurable disease as determined by local laboratory.
Participant consents to hospitalization requirements.
Participant consents to serial BMAs and/or BMBs during screening, study treatment, and at EOT.
Participant has an ECOG PS of 0 to 1
Participant with a history of RRMM who received 2 to 4 prior lines of anti-myeloma therapy.
Participants must have measurable disease as determined by local laboratory.
Participant consents to hospitalization requirements.
Participant consents to serial BMAs and/or BMBs during screening, study treatment, and at EOT.
Participant has an ECOG PS of 0 to 1
CRITERIOS DE EXCLUSIÓN
Participant with known current or history of CNS involvement of MM
Participant cannot tolerate oral medications and/or has gastrointestinal disease (within 3 months of screening) or any gastrointestinal surgery that may significantly alter the absorption of oral study treatment
Ongoing Grade 2 peripheral sensory or motor neuropathy.
History of GBS or GBS variants, or history of any Grade 3 peripheral motor polyneuropathy.
HIV positive patients.
Participant has known chronic, active HBV/HCV infection
Participant has a prior history of malignancies other than MM, except if the participant has been free of the disease for 3 years.
Participant has a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, or psychosis
Participant cannot tolerate oral medications and/or has gastrointestinal disease (within 3 months of screening) or any gastrointestinal surgery that may significantly alter the absorption of oral study treatment
Ongoing Grade 2 peripheral sensory or motor neuropathy.
History of GBS or GBS variants, or history of any Grade 3 peripheral motor polyneuropathy.
HIV positive patients.
Participant has known chronic, active HBV/HCV infection
Participant has a prior history of malignancies other than MM, except if the participant has been free of the disease for 3 years.
Participant has a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, or psychosis
DESCRIPCIÓN
The main goal is to determine the safety and tolerability of Mezigdomide in combination with Elranatamab in participants with RRMM and to determine the recommended Phase 2 dose (RP2D; the dose to be used in subsequent, larger studies) and schedule of Mezigdomide when given in combination in participants with RRMM.
PALABRAS CLAVE
multiple myeloma, myeloma, rrmm
