Ireland
--:--IST
Recruiting Observational

DAratumumab and REvlimid REfractory MM

NCT06541860 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-08-21
Last updated
2024-08-07

Condition(s) studied

Multiple Myeloma

Study summary

Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Phase I * Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme * Patients aged ≥ 18 years * Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data Phase II * Patients with RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS started on therapy with on-label schemes * Patients aged ≥ 18 years * Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data Exclusion Criteria: * Patients not willing to consent to review of clinical data

Primary outcome measure(s)

  • To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy. — 2 years
    Phase I - Retrospective study The primary objective is to estimate 2-year progression-free survival (PFS) of PVd when used in RRMM after anti-CD38 MoAb and IMIDS Phase II - Prospective study The primary objective is to estimate the 2-year progression-free survival (PFS) of the on-label combinations in patients with relapsed RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS

Trial sites (1)

FacilityCityRegionStatus
Irccs San Matteo Pavia Pavia PV Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06541860 on ClinicalTrials.gov ↗ ← All trials in Italy