Status:
COMPLETED
Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy
Lead Sponsor:
Fondazione EMN Italy Onlus
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Written informed consent may be obtained from the patient or legally authorized representative according to local regulations (patients who have already died may also be included)
- Histologically or cytologically confirmed diagnosis of MM as defined according to IMWG criteria of 2016 and:
- patient has undergone stem cells transplantation or is considered ineligible for transplantation, and
- patient has received at least four therapies
- patient is refractory to an anti-CD38 antibody (ex., daratumumab) alone or in combination, and to an IMiD (ex., lenalidomide or pomalidomide), and to a proteasome inhibitor (ex. bortezomib, ixazomib or carfilzomib).
- Male or female equal and/or upper 18 years (at baseline)
- Performance Status at baseline by ECOG scale 0-2
- Adequate organ system functions at baseline
- Female patients: a female patient is elegible if she is not pregnant or breastfeeding and at least one of the following conditions applies:
- She is/was not a woman of childbearing potential (WOCBP) OR
- She is/was using an highly effective contrapcetive method during the treatment period and at least 9 months after the last dose and she agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
- Highly sensitive negative serum pregnancy test within 72 hours of therapy (C1D1) and agreed to use effective contraception during the treatment period and for the next 9 months after the last dose of the drug.
- Male patient: male patient were/are elegible if agreed to follow from the first dose until the last dose of treatment to allow clearance of any altered sperm:
- abstaining from sperm donation PLUS
- abstaing from heterosexual relationship in accordance with one's preferred and habitual lifestyle (long-term and persistent abstinent) and agreed/accepted to remain abstinent OR
- agree/agreed to use contraption as described below: agree to use male condom even though they have/had succesfully vasectomy and female partner uses/used an additional highly effective contraceptive method.
- All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) were Grade 1 or less at t at the time of treatment initiation within compassionate use programs, except alopecia and neuropathy grade 2.
Exclusion
- The patients are/were not elegible for compassionate use programs (NPP, EAP)
Key Trial Info
Start Date :
July 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05393024
Start Date
July 22 2022
End Date
August 12 2024
Last Update
January 15 2025
Active Locations (10)
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1
AOU Ospedali Riuniti Umberto I
Ancona, Italy
2
Policlinico Sant'Orsola Malpighi, Aou Di Bologna
Bologna, Italy
3
A.O. Spedali Civili di Brescia
Brescia, Italy
4
Ospedale "A. Businco"
Cagliari, Italy