Cilta-cel
DrugCilta-cel infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg).
NCT Number: NCT04181827
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Royal Adelaide Hospital, Adelaide, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cilta-cel infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg).
Pomalidomide 4 mg will be administered orally.
Bortezomib 1.3 milligram per meter square (mg/m^2) will be administered subcutaneously (SC).
Dexamethasone 20 mg/day (10mg/day for participants >75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants >75 years of age) in DPd treatment.
Daratumumab 1800 mg will be administered SC.
Time frame: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be >=0.5 grams per deciliter [g/dL] and >=200 milligrams [mg] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of >10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of >=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, >=50% increase in circulating PCs (minimum of 200 cells per microliter [uL]) if this was only measure of disease.
Time frame: From randomization (Day 1) up to 7 years
Time frame: From randomization (Day 1) up to 7 years
Time frame: From randomization (Day 1) up to 12 months +/- 3 months
Time frame: From randomization (Day 1) up to 7 years
Time frame: From randomization (Day 1) up to 7 years
Time frame: From randomization (Day 1) up to 7 years
Time frame: From randomization (Day 1) up to 7 years
Time frame: From randomization (Day 1) up to 7 years
Time frame: From Cycle 1 Day 1 up to 7 years
Time frame: From Cycle 1 Day 1 up to 7 years
Time frame: From baseline (Cycle 1 Day 1) up to 7 years
Time frame: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Time frame: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Time frame: From Cycle 1 Day 1 up to 7 years
Time frame: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Time frame: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Time frame: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Time frame: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Time frame: From randomization (Day 1) up to 7 years
Janssen Research & Development, LLC
Industry
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma
Acronym: CARTITUDE-4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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