Multiple Myeloma
Conditions
Brief 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.
Interventions
None listed
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed