C1071032 - MAGNETISMM-32 A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Conditions

Relapsed/Refractory Multiple Myeloma

Brief summary

PFS (progression free survival) by BICR (blinded independent central review) per IMWG (International Myeloma Working Group)

Detailed description

OS (overall survival), • PFS by Investigator per IMWG • PFS2 (PFS on next line therapy) by Investigator per IMWG • ORR (objective response rate) by BICR per IMWG • DOR (duration of response) by BICR per IMWG • VGPRR (very good partial response rate) (≥VGPR) (very good partial response) by BICR per IMWG • CRR (complete response rate) by BICR per IMWG • DOCR (duration of complete response) by BICR per IMWG • TTR (time to response) by BICR per IMWG, • AEs (adverse events) • Laboratory abnormalities, •PFS by BICR per IMWG •OS (overall survival) •PFS and PFS2 by Investigator per IMWG •ORR by BICR per IMWG • DOR by BICR per IMWG • VGPRR by BICR per IMWG •CRR by BICR per IMWG •DOCR by BICR per IMWG •TTR by BICR per IMWG •MRD negativity rate per IMWG •Sustained MRD negativity rate for at least 12 months per IMWG •AEs •Laboratory abnormalities, Pre- and post-dose concentrations of elranatamab, ADA (antidrug antibody) and NAb (neutralizing antibody) against elranatamab, • Change from baseline EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire 30) scores (global health, fatigue, pain, physical functioning, role functioning, and emotional functioning domains) • Change from baseline MY20 (multiple myeloma module quality of life questionnaire) scores (disease symptoms, side-effects of treatment, body image, and future perspective domains)

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKyprolis 60 mg powder for solution for infusion

DRUGImnovid 2 mg hard capsules

DRUGEmpliciti 400 mg powder for concentrate for solution for infusion.

DRUGImnovid 4 mg hard capsules

DRUGDexamethason 4 mg JENAPHARM®

DRUGImnovid 1 mg hard capsules

DRUGNodexon 20 mg tabletes

DRUGELRANATAMAB

DRUGPrivigen 100 mg/ml solution for infusion

DRUGDexamethason 0

DRUG5 mg JENAPHARM®

DRUGBortezomib STADA 2

DRUG5 mg/ml Injektionslösung

DRUGImnovid 3 mg hard capsules

DRUGNodexon 20 mg tabletės

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS (progression free survival) by BICR (blinded independent central review) per IMWG (International Myeloma Working Group)	—

Secondary

Measure	Time frame
OS (overall survival), • PFS by Investigator per IMWG • PFS2 (PFS on next line therapy) by Investigator per IMWG • ORR (objective response rate) by BICR per IMWG • DOR (duration of response) by BICR per IMWG • VGPRR (very good partial response rate) (≥VGPR) (very good partial response) by BICR per IMWG • CRR (complete response rate) by BICR per IMWG • DOCR (duration of complete response) by BICR per IMWG • TTR (time to response) by BICR per IMWG, • AEs (adverse events) • Laboratory abnormalities, •PFS by BICR per IMWG •OS (overall survival) •PFS and PFS2 by Investigator per IMWG •ORR by BICR per IMWG • DOR by BICR per IMWG • VGPRR by BICR per IMWG •CRR by BICR per IMWG •DOCR by BICR per IMWG •TTR by BICR per IMWG •MRD negativity rate per IMWG •Sustained MRD negativity rate for at least 12 months per IMWG •AEs •Laboratory abnormalities, Pre- and post-dose concentrations of elranatamab, ADA (antidrug antibody) and NAb (neutralizing antibody) against elranatamab, • Change from baseline E	—

Measure

Time frame

OS (overall survival), • PFS by Investigator per IMWG • PFS2 (PFS on next line therapy) by Investigator per IMWG • ORR (objective response rate) by BICR per IMWG • DOR (duration of response) by BICR per IMWG • VGPRR (very good partial response rate) (≥VGPR) (very good partial response) by BICR per IMWG • CRR (complete response rate) by BICR per IMWG • DOCR (duration of complete response) by BICR per IMWG • TTR (time to response) by BICR per IMWG, • AEs (adverse events) • Laboratory abnormalities, •PFS by BICR per IMWG •OS (overall survival) •PFS and PFS2 by Investigator per IMWG •ORR by BICR per IMWG • DOR by BICR per IMWG • VGPRR by BICR per IMWG •CRR by BICR per IMWG •DOCR by BICR per IMWG •TTR by BICR per IMWG •MRD negativity rate per IMWG •Sustained MRD negativity rate for at least 12 months per IMWG •AEs •Laboratory abnormalities, Pre- and post-dose concentrations of elranatamab, ADA (antidrug antibody) and NAb (neutralizing antibody) against elranatamab, • Change from baseline E

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Countries

Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed