This is a retrospective/prospective observational study evaluating the efficacy and safety of Belantamab Mafotidin as a single agent in patients with Multiple Myeloma Relapse/Refractory (MMRR) treated in clinical pratice under compassionate use
Multiple myeloma (MM) is an incurable disease that accounts for 1% of all cancers and 10% of all haematological malignancies, most patients with MM develop resistance to existing therapies at the time of disease recurrence. Belantamab mafodotin is a new humanized antibody-drug conjugate (IgG1) that is under development for the treatment of MM and has demonstrated a manageable safety profile and positive clinical activity in patients with relapsed or refractory multiple myeloma (MMRR) heavily pretreated. The objective of this retro-prospective observational study is: to evaluate clinical efficacy as the percentage of patients who have achieved a clinical benefit (minimum or best response), ORR, DoR, PFS, OS; evaluate the safety profile of patients treated with Belantamab Mafodotin as monotherapy in clinical practice. All patients included in this analysis were treated or are still receiving Belantamab Mafodotin monotherapy under the compassionate use programs (nominal program-NPP and the extended access program-EAP).
Study Type
OBSERVATIONAL
Enrollment
78
MMRR patients included in Named Patient Program e Expanded Access Program
AOU Ospedali Riuniti Umberto I
Ancona, Italy
Policlinico Sant'Orsola Malpighi, Aou Di Bologna
Bologna, Italy
A.O. Spedali Civili di Brescia
Brescia, Italy
Ospedale "A. Businco"
Cagliari, Italy
Best response or minimal response
percentage of patients that achieved a clinical benefit
Time frame: 1 year
Overall Response Rate (ORR)
percertange of patient with confirmed partial response
Time frame: 1 year
Progression Free Survival (PFS)
time from the first Belantamab Mafodotin administration until disease progression
Time frame: 1 year
Duration of Response (DoR)
time for first documentated partial or best response until disease progression
Time frame: 1 year
Overall Survival
time from starting of treatment until death or other cause
Time frame: 1 year
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AOU Policlinico Vittorio Emanuele
Catania, Italy
A.O.U. Arcispedale Sant'Anna
Ferrara, Italy
Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
Milan, Italy
A.O.U. Federico II
Naples, Italy
La Maddalena S.p.a
Palermo, Italy
Policlinico Umberto I - Università La Sapienza
Roma, Italy