Multiple myeloma
Conditions
Brief summary
• ORR by BICR per IMWG.
Detailed description
• ORR by BICR baseline EMD status per IMWG., • DOR by BICR and investigator per IMWG., • CRR by BICR and investigator per IMWG., • ORR by investigator per IMWG., • DOCR by BICR and investigator per IMWG., • PFS by BICR and investigator per IMWG., • TTR by BICR and investigator per IMWG., • MRD negativity rate (central lab) per IMWG., • AEs and laboratory abnormalities as graded by NCI CTCAE v5.0., • Severity of CRS and ICANS assessed according to ASTCT criteria., • Pre- and postdose concentrations of elranatamab., • ADAs and NAbs against elranatamab., • OS.
Interventions
DRUGELRANATAMAB
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • ORR by BICR per IMWG. | — |
Secondary
| Measure | Time frame |
|---|---|
| • ORR by BICR baseline EMD status per IMWG., • DOR by BICR and investigator per IMWG., • CRR by BICR and investigator per IMWG., • ORR by investigator per IMWG., • DOCR by BICR and investigator per IMWG., • PFS by BICR and investigator per IMWG., • TTR by BICR and investigator per IMWG., • MRD negativity rate (central lab) per IMWG., • AEs and laboratory abnormalities as graded by NCI CTCAE v5.0., • Severity of CRS and ICANS assessed according to ASTCT criteria., • Pre- and postdose concentrations of elranatamab., • ADAs and NAbs against elranatamab., • OS. | — |
Countries
Belgium, France, Germany, Poland, Spain
Outcome results
None listed