Relapsed/Refractory Multiple Myeloma
Conditions
Brief summary
Alive and free of treatment emergent ASTCT Grade ≥2 CRS without the use of additional intervening treatment for CRS of any grade.
Detailed description
Treatment-emergent CRS of any ASTCT Grade, Grade ≥2, and Grade ≥3 by the end of Day28 from the ramantamig step-up dose, respectively. Treatment-emergent CRS of any ASTCT Grade, Grade ≥2, and Grade ≥3 during the course of ramantamig treatment. Re-occurrence of CRS with ASTCT Grade ≥2 after the initial occurrence of treatment-emergent Grade ≥2 CRS event, and re-occurrence of CRS for all Grades., ORR (PR or better response); CR or better response, VGPR or better response as defined by the IMWG response criteria. DOR TTR PFS TTNT, AE occurrence and severityas well as cytopenia and infections, laboratory results, and other safety parameters.
Interventions
Sponsors
Janssen Cilag International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alive and free of treatment emergent ASTCT Grade ≥2 CRS without the use of additional intervening treatment for CRS of any grade. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-emergent CRS of any ASTCT Grade, Grade ≥2, and Grade ≥3 by the end of Day28 from the ramantamig step-up dose, respectively. Treatment-emergent CRS of any ASTCT Grade, Grade ≥2, and Grade ≥3 during the course of ramantamig treatment. Re-occurrence of CRS with ASTCT Grade ≥2 after the initial occurrence of treatment-emergent Grade ≥2 CRS event, and re-occurrence of CRS for all Grades., ORR (PR or better response); CR or better response, VGPR or better response as defined by the IMWG response criteria. DOR TTR PFS TTNT, AE occurrence and severityas well as cytopenia and infections, laboratory results, and other safety parameters. | — |
Outcome results
None listed