A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522007-18-00

Enrollment

Registered

2026-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Multiple Myeloma

Brief summary

Dual primary endpoints: overall response rate, progression-free survival

Detailed description

"VGPR or better CR or better Duration of response MRD-negative CR MRD-negative CR at 9 months Sustained MRD-negative CR (duration ≥12 months) PFS2 OS TTNT", TEAE incidence and severity, laboratory results, and other safety parameters, Change from baseline in HRQoL, symptoms, and functioning using the MySIm-Q, EORTC QLQ-C30, and EQ-5D-5L scores Time to worsening in HRQoL, symptoms, and functioning using the MySIm-Q, EORTC QLQ-C30, and EQ-5D-5L scores Percent of participants with meaningful improvement in HRQoL symptoms, and functioning using the MySIm-Q, EORTC QLQ-C30, and EQ-5D-5L scores, Proportion of participants who report side effects burden on the EORTC IL46, JNJ-79635322 serum concentration, Presence of ADAs and neutralizing antibodies to JNJ-79635322

Interventions

DRUGteclistamab

DRUGJNJ-79635322

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dual primary endpoints: overall response rate, progression-free survival	—

Secondary

Measure	Time frame
"VGPR or better CR or better Duration of response MRD-negative CR MRD-negative CR at 9 months Sustained MRD-negative CR (duration ≥12 months) PFS2 OS TTNT", TEAE incidence and severity, laboratory results, and other safety parameters, Change from baseline in HRQoL, symptoms, and functioning using the MySIm-Q, EORTC QLQ-C30, and EQ-5D-5L scores Time to worsening in HRQoL, symptoms, and functioning using the MySIm-Q, EORTC QLQ-C30, and EQ-5D-5L scores Percent of participants with meaningful improvement in HRQoL symptoms, and functioning using the MySIm-Q, EORTC QLQ-C30, and EQ-5D-5L scores, Proportion of participants who report side effects burden on the EORTC IL46, JNJ-79635322 serum concentration, Presence of ADAs and neutralizing antibodies to JNJ-79635322	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: May 20, 2026