HO183 CAR T: A phase III randomized trial comparing academically produced BCMA-directed CAR T-cells (ARI0002h) with standard of care regimen in patients with relapsed/refractory multiple myeloma

Conditions

relapsed/refractory multiple myeloma

Brief summary

Progression free survival

Detailed description

Safety and toxicity of ARI0002h CAR T-cells and SoC, Overall response rate, Overall and sustained MRD-negativity, MRD-negative CR/sCR and MRD-negative VGPR+, Correlation of MRD-negativity with efficacy endpoints, Best overall response, Duration of response, Overall survival from date of randomization, Patient Reported Outcome/Quality of Life, CAR T-cell expansion, persistence, and T-cell characteristics in ARI0002h-treated patients, PoC CAR T-cell production characteristics, The association of the functional characteristics of the CAR T-cell products with CAR T-cell expansion, persistence, AEs, response rates and PFS, Proportion of successful batches, Production and additional health care costs

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKyprolis 60 mg powder for solution for infusion

DRUGKyprolis 30 mg powder for solution for infusion

DRUGDARZALEX 1800 mg solution for injection

DRUGENDOXAN omhulde tablet

DRUGomhulde tabletten

DRUG50 mg

DRUGCesnicabtagene autoleucel

DRUGKyprolis 10 mg powder for solution for infusion

DRUGDexamethason Teva 4 mg

DRUGtabletten

DRUGBortezomib Accord 3.5 mg powder for solution for injection

DRUGEmpliciti 300 mg powder for concentrate for solution for infusion.

DRUGDexamethason Activase 2 mg tabletten

DRUGPomalidomide Accord 4 mg hard capsules

DRUGEmpliciti 400 mg powder for concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Safety and toxicity of ARI0002h CAR T-cells and SoC, Overall response rate, Overall and sustained MRD-negativity, MRD-negative CR/sCR and MRD-negative VGPR+, Correlation of MRD-negativity with efficacy endpoints, Best overall response, Duration of response, Overall survival from date of randomization, Patient Reported Outcome/Quality of Life, CAR T-cell expansion, persistence, and T-cell characteristics in ARI0002h-treated patients, PoC CAR T-cell production characteristics, The association of the functional characteristics of the CAR T-cell products with CAR T-cell expansion, persistence, AEs, response rates and PFS, Proportion of successful batches, Production and additional health care costs	—

Measure

Time frame

Safety and toxicity of ARI0002h CAR T-cells and SoC, Overall response rate, Overall and sustained MRD-negativity, MRD-negative CR/sCR and MRD-negative VGPR+, Correlation of MRD-negativity with efficacy endpoints, Best overall response, Duration of response, Overall survival from date of randomization, Patient Reported Outcome/Quality of Life, CAR T-cell expansion, persistence, and T-cell characteristics in ARI0002h-treated patients, PoC CAR T-cell production characteristics, The association of the functional characteristics of the CAR T-cell products with CAR T-cell expansion, persistence, AEs, response rates and PFS, Proportion of successful batches, Production and additional health care costs

—

Outcome results

None listed