ISKPD-IFM2018-03-Multicenter Open label Phase 2 study of Isatuximab plus Pomalidomide and Dexamethasone with Carfilzomib in Relapsed or Refractory Multiple Myeloma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516670-29-00

Enrollment

Registered

2024-08-19

Start date

2020-09-15

Completion date

2025-09-26

Last updated

2025-06-02

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

Conditions

Multiple Myeloma

Brief summary

MRD 10-5 incidence rate determined (as the best response obtained at any time point during treatment) as per IMWG criteria by NGS (centrally performed, Pr Avet Loiseau Toulouse Oncopole).

Detailed description

Treatment emergent adverse events of IsPd +K will be evaluated according to CTCAE 5.0., To determine Overall Response Rate (ORR, Partial Response and better), Very Good Partial Response (VGPR) + CR rate of IsPd +K as per IMWG criteria and with M protein interference testing. Clinical benefit response rate (CBR, Minor Response (MR) and better) of IsPd +K as per IMWG criteria., Time to response and Response duration for responders as per IMWG criteria., Overall Survival (OS), Progression free survival (PFS), Time To Progression (TTP), Time To Next Therapy (TTNT) and Event Free survival (EFS) of IsPd +K will be evaluated as per IMWG criteria.

Interventions

DRUGImnovid 4 mg hard capsules

DRUGDEXAMETHASONE

DRUGImnovid 2 mg hard capsules

DRUGKyprolis 60 mg powder for solution for infusion

DRUGImnovid 1 mg hard capsules

DRUGImnovid 3 mg hard capsules

DRUGSARCLISA 20mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MRD 10-5 incidence rate determined (as the best response obtained at any time point during treatment) as per IMWG criteria by NGS (centrally performed, Pr Avet Loiseau Toulouse Oncopole).	—

Secondary

Measure	Time frame
Treatment emergent adverse events of IsPd +K will be evaluated according to CTCAE 5.0., To determine Overall Response Rate (ORR, Partial Response and better), Very Good Partial Response (VGPR) + CR rate of IsPd +K as per IMWG criteria and with M protein interference testing. Clinical benefit response rate (CBR, Minor Response (MR) and better) of IsPd +K as per IMWG criteria., Time to response and Response duration for responders as per IMWG criteria., Overall Survival (OS), Progression free survival (PFS), Time To Progression (TTP), Time To Next Therapy (TTNT) and Event Free survival (EFS) of IsPd +K will be evaluated as per IMWG criteria.	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026