Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy

Other

• The patients are/were not elegible for compassionate use programs (NPP, EAP)

• 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.