A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

Phase 3

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT05257083
• Lead Sponsor: Stichting European Myeloma Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-2-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Participants with documented NDMM according to IMWG diagnostic criteria, for whom<br> high-dose therapy and ASCT are part of the intended initial treatment plan.<br><br> - Measurable disease, as assessed by central laboratory, at screening as defined by<br> any of the following:<br><br> 1. Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein<br> level =200 mg/24 hours; or<br><br> 2. Light chain MM without measurable disease in serum or urine: serum Ig<br> free-light chain (FLC) =10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.<br><br> - ECOG performance status of grade 0 or 1<br><br> - Clinical laboratory values within prespecified range.<br><br>Exclusion Criteria:<br><br> - Prior treatment with CAR-T therapy directed at any target.<br><br> - Any prior BCMA target therapy.<br><br> - Any prior therapy for MM or smoldering myeloma other than a short course of<br> corticosteroids<br><br> - Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to<br> randomization<br><br> - Received or plans to receive any live, attenuated vaccine (except for COVID-19<br> vaccines) within 4 weeks prior to randomization.<br><br> - Known active, or prior history of central nervous system (CNS) involvement or<br> clinical signs of meningeal involvement of MM<br><br> - Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS);Sustained MRD-negative CR

Secondary Outcome Measures

Name	Time	Method
Overall Response (OR);Complete Response (CR) or better status;Overall Minimal Residual Disease (MRD) -negative CR;Time to subsequent antimyeloma therapy;Progression Free Survival on Next-line Therapy (PFS2);Overall Survival (OS);Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score;Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score;Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Scor;Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score;Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)