A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

Phase 3

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Biological: idecabtagene vicleucel; Drug: Lenalidomide; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT06045806
• Lead Sponsor: Celgene

Brief Summary

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Study Start: 2023-10-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-08-11
• Study Completion: 2025-08-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	idecabtagene vicleucel	-
Arm A	Lenalidomide	-
Arm A	Cyclophosphamide	-
Arm A	Fludarabine	-
Arm B	Lenalidomide	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to approximately 50 months after the first participant is randomized	PFS as assessed by Independent Review Committee (IRC)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months	From randomization up to 60 months from randomization
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)	From randomization up to 15 months from randomization
Event-Free Survival (EFS)	Up to approximately 60 months after the last participant is randomized
Duration of Response (DOR)	Up to approximately 60 months after the last participant is randomized
Maximum Observed Plasma Concentration (Cmax)	Up to approximately 60 months after the last participant is randomized
Time of Maximum Observed Plasma Concentration (Tmax)	Up to approximately 60 months after the last participant is randomized
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])	Up to 28 days post infusion
Time of Last Measurable Observed Plasma Concentration (Tlast)	Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Complete Response (CR)	Up to approximately 60 months after the last participant is randomized	CR as assessed by IRC
Time to Progression (TTP)	Up to approximately 60 months after the last participant is randomized	Progression as assessed by IRC
Progression post-next line of treatment (PFS2)	Up to approximately 60 months after the last participant is randomized
Time to Next Treatment (TTNT)	Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events (AEs)	Up to approximately 60 months after the last participant is randomized
Number of Participants Experiencing Adverse Events of Special Interest (AESI)	Up to approximately 60 months after the last participant is randomized
Time-to-Definitive Deterioration	Up to approximately 50 months after the first participant is randomized	Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales	Up to approximately 50 months after the first participant is randomized	The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed: * Global health status/quality of life; * Physical Functioning; * Fatigue; * Pain
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales	Up to approximately 50 months after the first participant is randomized	The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed: * Disease symptoms; * Side-effects of treatment

Trial Locations

Locations (100)

Local Institution - 0131; 🇺🇸 Los Angeles, California, United States

Local Institution - 0126; 🇺🇸 Orange, California, United States

Local Institution - 0113; 🇺🇸 Sacramento, California, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Local Institution - 0121; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0104; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0151; 🇺🇸 Boston, Massachusetts, United States

Ascension Providence Hospital; 🇺🇸 Southfield, Michigan, United States

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