A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

Conditions

Newly Diagnosed Multiple Myeloma with Suboptimal Response After Autologous Stem Cell Transplantation

Brief summary

Progression Free Survival (PFS)

Detailed description

Overal Surival (OS), Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months, Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR), Event-Free Survival (EFS), Duration of Response (DOR), Percentage of Participants with Complete Response (CR), Time to Progression (TTP), Progression post-next line of treatment (PFS2), Time to Next Treatment (TTNT), Number of Participants Experiencing Adverse Events (AEs)., Number of Participants Experiencing Adverse Events of Special Interest (AESI), Maximum Observed Plasma Concentration (Cmax), Time of Maximum Observed Plasma Concentration (Tmax), Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0-28D]), Time of Last Measurable Observed Plasma Concentration (Tlast), Time-to-Definitive Deterioration, Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales, Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales

Related papers

No related papers found yet.

Interventions

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGDIPHENHYDRAMINE HYDROCHLORIDE

DRUGRevlimid 10 mg hard capsules

DRUGRevlimid 5 mg hard capsules

DRUGidecabtagene vicleucel

DRUGFludarabine Accord

DRUG25 mg/ml

DRUGkoncentrat do sporzadzania roztworu do wstrzykiwan lub infuzji

DRUGEndoxan

DRUGNeoflubin 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung

DRUGRevlimid 15 mg hard capsules

DRUGBendarabin 50 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung

DRUGFLUDARABINE ACCORD 25 mg/ml

DRUGsolution à diluer pour solution injectable/pour perfusion

DRUGFludarabinphosphat-GRY® 25 mg/ml Konzentrat zur Herstellung einer Injektionslösung oder Infusionslösung

DRUGFludarabin HEXAL® 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung

DRUGPARACETAMOL

DRUGRevlimid 2.5 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS)	—

Secondary

Measure	Time frame
Overal Surival (OS), Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months, Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR), Event-Free Survival (EFS), Duration of Response (DOR), Percentage of Participants with Complete Response (CR), Time to Progression (TTP), Progression post-next line of treatment (PFS2), Time to Next Treatment (TTNT), Number of Participants Experiencing Adverse Events (AEs)., Number of Participants Experiencing Adverse Events of Special Interest (AESI), Maximum Observed Plasma Concentration (Cmax), Time of Maximum Observed Plasma Concentration (Tmax), Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0-28D]), Time of Last Measurable Observed Plasma Concentration (Tlast), Time-to-Definitive Deterioration, Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales, Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales	—

Measure

Time frame

Overal Surival (OS), Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months, Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR), Event-Free Survival (EFS), Duration of Response (DOR), Percentage of Participants with Complete Response (CR), Time to Progression (TTP), Progression post-next line of treatment (PFS2), Time to Next Treatment (TTNT), Number of Participants Experiencing Adverse Events (AEs)., Number of Participants Experiencing Adverse Events of Special Interest (AESI), Maximum Observed Plasma Concentration (Cmax), Time of Maximum Observed Plasma Concentration (Tmax), Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0-28D]), Time of Last Measurable Observed Plasma Concentration (Tlast), Time-to-Definitive Deterioration, Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales, Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales

—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Norway, Poland, Romania, Spain

Outcome results

None listed