DAratumumab and REvlimid REfractory MM
Recruiting
- Conditions
- Multiple Myeloma
- Registration Number
- NCT06541860
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Irccs San Matteo Pavia
🇮🇹Pavia, PV, Italy
Irccs San Matteo Pavia🇮🇹Pavia, PV, Italy