A Phase 2 Study of Teclistamab in Combination with Daratumumab or Lenalidomide in Elderly Patients with Newly Diagnosed Multiple Myeloma - IFM2021-01

Conditions

Multiple Myeloma

Brief summary

Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len.

Detailed description

ORR, (PR or better) as defined by the IMWG response criteria after 2 cycles of treatment, Treatment-emergent adverse events as defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE, version 5.0)., - ORR, (PR or better) as defined by the IMWG response criteria. - VGPR or better - Complete response (CR) or better - Time to Response - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Time to treatment failure (time from date of inclusion to discontinuation of treatment for any reason, including death, progression, toxicity) - Time to Next Treatment (TTNT), - MRD negativity (at the 10-5 and 10-6 level by next generation sequencing [NGS]) at 6 months. - Sustained MRD negativity (at the 10-5 and 10-6 level by NGS) at 18 months (12 months after the initial MRD point).

Related papers

No related papers found yet.

Interventions

DRUGTECLISTAMAB

DRUGDARATUMUMAB

DRUGLENALIDOMIDE

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len.	—

Secondary

Measure	Time frame
ORR, (PR or better) as defined by the IMWG response criteria after 2 cycles of treatment, Treatment-emergent adverse events as defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE, version 5.0)., - ORR, (PR or better) as defined by the IMWG response criteria. - VGPR or better - Complete response (CR) or better - Time to Response - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Time to treatment failure (time from date of inclusion to discontinuation of treatment for any reason, including death, progression, toxicity) - Time to Next Treatment (TTNT), - MRD negativity (at the 10-5 and 10-6 level by next generation sequencing [NGS]) at 6 months. - Sustained MRD negativity (at the 10-5 and 10-6 level by NGS) at 18 months (12 months after the initial MRD point).	—

Measure

Time frame

ORR, (PR or better) as defined by the IMWG response criteria after 2 cycles of treatment, Treatment-emergent adverse events as defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE, version 5.0)., - ORR, (PR or better) as defined by the IMWG response criteria. - VGPR or better - Complete response (CR) or better - Time to Response - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Time to treatment failure (time from date of inclusion to discontinuation of treatment for any reason, including death, progression, toxicity) - Time to Next Treatment (TTNT), - MRD negativity (at the 10-5 and 10-6 level by next generation sequencing [NGS]) at 6 months. - Sustained MRD negativity (at the 10-5 and 10-6 level by NGS) at 18 months (12 months after the initial MRD point).

—

Countries

France

Outcome results

None listed