A Double-Blind, Randomized, Active Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia mieloide aguda, Mieloma Múltiple y otras gammapatías
FECHA DE APERTURA
Agosto, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Male or female with 18 years of age or older.
Patient must have documented multiple myeloma (MM).
Patient must have a documented relapsed or refractory disease.
Patient must have achieved a response (PR or better based on investigators determination of response by the IMWG criteria) to at least one prior regimen.
Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.
Patient must have received at least 1, but maximum 3 prior lines of therapy for MM.
Patient must have documented multiple myeloma (MM).
Patient must have a documented relapsed or refractory disease.
Patient must have achieved a response (PR or better based on investigators determination of response by the IMWG criteria) to at least one prior regimen.
Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.
Patient must have received at least 1, but maximum 3 prior lines of therapy for MM.
CRITERIOS DE EXCLUSIÓN
Patient has received daratumumab or any other drug specifically targeting CD38 previously.
Patients disease shows evidence of refractoriness or intolerance to lenalidomide. If previously treated with a lenalidomide-containing regimen, the patient is excluded if he or she: a) Discontinued due to any AEs related to prior lenalidomide treatment, or b) If, at any time point, the patient was refractory to any dose of lenalidomide.
Patient has received a prior treatment with one or more of the followings: a) Approved anti-myeloma agents within 14 days or 5 PK half-lives of the treatment, whichever is longer, before the date of randomization. Note. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum 4 days) before Day 1 of Cycle 1. b) Current or recent treatment (within 28 days before randomization or 5 half-lives, whichever is longer) with any other investigational medicinal product or device. c) Radiation therapy within 14 days of randomization. Patients must have recovered from all radiation-related toxicities. d) Plasmapheresis within 28 days of randomization. e) Live or live-attenuated vaccine, or all coronavirus disease-19 (COVID-19) vaccines within 14 days prior to randomization.
Patient has received ASCT within 12 weeks before the date of randomization, or the patients immune system has not sufficiently recovered after ASCT under the investigator's judgment.
Patient has previously received an allogenic stem cell transplant regardless of timing.
Patients disease shows evidence of refractoriness or intolerance to lenalidomide. If previously treated with a lenalidomide-containing regimen, the patient is excluded if he or she: a) Discontinued due to any AEs related to prior lenalidomide treatment, or b) If, at any time point, the patient was refractory to any dose of lenalidomide.
Patient has received a prior treatment with one or more of the followings: a) Approved anti-myeloma agents within 14 days or 5 PK half-lives of the treatment, whichever is longer, before the date of randomization. Note. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum 4 days) before Day 1 of Cycle 1. b) Current or recent treatment (within 28 days before randomization or 5 half-lives, whichever is longer) with any other investigational medicinal product or device. c) Radiation therapy within 14 days of randomization. Patients must have recovered from all radiation-related toxicities. d) Plasmapheresis within 28 days of randomization. e) Live or live-attenuated vaccine, or all coronavirus disease-19 (COVID-19) vaccines within 14 days prior to randomization.
Patient has received ASCT within 12 weeks before the date of randomization, or the patients immune system has not sufficiently recovered after ASCT under the investigator's judgment.
Patient has previously received an allogenic stem cell transplant regardless of timing.
DESCRIPCIÓN
The primary objective of this study is to demonstrate the PK similarity of CT-P44 and Darzalex Faspro in the PK Group and therapeutic equivalence of CT-P44 and Darzalex Faspro in the Main Study Group. All patients in the PK Group and non-PK Group will be included in the Main Study Group. The PK equivalence of CT-P44 and Darzalex Faspro will be demonstrated in terms of area under the concentration-time curve from Week 0 to Week 1 (AUCWeek0-1) and area under the concentration-time curve from Week 8 to Week 10 (AUCWeek8-10) of daratumumab in the PK setPK Group at 1st dose, and PK setPK Group up to 9th doses, respectively. The therapeutic equivalence of CT-P44 and Darzalex Faspro will be demonstrated in terms of proportion of patients who will achieve very good partial response (VGPR) or better based on the confirmed best overall response (BOR) up to Week 24 from the last patients randomization according to the IMWG criteria in the intent-to-treat (ITT) set.
PALABRAS CLAVE
multiple myeloma, myeloma, ph + acute lymphoblastic leukemia
