DAratumumab and REvlimid REfractory MM

Fondazione IRCCS Policlinico San Matteo di Pavia100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Irccs San Matteo Pavia

Pavia, PV, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

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

Time frame: 2 years

Data from ClinicalTrials.gov

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