PRE-emptive DAratumumab Therapy Of minimal Residual disease reappearance or biochemical relapse in multiple myeloma (PREDATOR).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518400-50-00

Acronym

PMC008

Enrollment

274

Registered

2024-12-02

Start date

2018-11-14

Completion date

2025-11-26

Last updated

2025-12-05

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

Conditions

Multiple Myeloma and Minimal Residual Disease

Brief summary

To compare (EFS) between daratumumab arm and observation arm after randomization of patients with biochemical relapse of MM. To compare (EFS) between daratumumab arm and observation arm after randomization of patients with reappearance of MRD in MM.

Detailed description

SPR, CRAB or death. Overall response rate (ORR) as determined by Investigator evaluation, defined as the percentage of subjects achieving an objective response (i.e., partial response or better), using the IMWG Consensus Panel 1 response criteria.

Interventions

DRUGDARZALEX 1800 mg solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To compare (EFS) between daratumumab arm and observation arm after randomization of patients with biochemical relapse of MM. To compare (EFS) between daratumumab arm and observation arm after randomization of patients with reappearance of MRD in MM.	—

Secondary

Measure	Time frame
SPR, CRAB or death. Overall response rate (ORR) as determined by Investigator evaluation, defined as the percentage of subjects achieving an objective response (i.e., partial response or better), using the IMWG Consensus Panel 1 response criteria.	—

Countries

Poland

Outcome results

None listed

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