Study Summary
This trial tests if cilta-cel, with cyclophosphamide and fludarabine, can safely and effectively treat high-risk, smoldering myeloma.
- Smoldering Multiple Myeloma
- Multiple Myeloma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 9 Secondary · Reporting Duration: 24 months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Safety Run-In
1 of 2
Cilta-Cel Dose Expansion Cohort
1 of 2
Experimental Treatment
20 Total Participants · 2 Treatment Groups
Primary Treatment: Safety Run-In · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are participants in the Safety Run-In study adequately protected?
"The safety of Safety Run-In is provisionally rated a 2, as there are evidence suggesting its protection but none that confirm its effectiveness." - Anonymous Online Contributor
Is there still availability for participants in this investigation?
"Clinicaltrials.gov data suggests that this study, which began on the 1st of May 2023 and was last updated on March 2nd 2023, is not actively recruiting for participants. However, 807 other trials are currently searching for patients to join their clinical research." - Anonymous Online Contributor
What are the core aims of this research endeavor?
"This clinical trial will take approximately 24 months to evaluate Nature of Dose Limiting Toxicities (DLT) and measure a variety of secondary outcomes. These include Overall Response Rate (ORR), defined as the proportion of participants with the best possible response, Complete Response Rate which is determined by local investigators using International Myeloma Working Group Criteria (Kumar et al, 2016), and Duration of Response, measured from when an individual achieves their desired result until relapse or death due to [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) occurs." - Anonymous Online Contributor