BelaCarD: Looking at how well a targeted combination treatment works for people with multiple myeloma that has come back or not responded to previous treatment (RRMM)A phase I/II single arm study on the efficacy of combination Belantamab Mafodotin, Carfilzomib, Dexamethasone in patients with early relapsed multiple myeloma

Inclusion

Participants must have:
1. Male or female, 18 years or older, capable of giving consent.
2. Have confirmed MM as defined by IMWG criteria.
3. ECOG Performance Status 0-2.
4. Have had at least 1 and no more than 3 prior lines of therapy.
5. Must have measurable disease defined as at least one of:
o Serum M-protein concentration of greater than or equal to 5g/L
o Urine M-protein excretion greater than or equal to 200mg/24hr or
o Serum free light chain (FLC) assay: involved FLC level greater than or equal to 100mg/L and an abnormal serum free light chain ration (less than 0.26 or greater than 1.65)
6. Adequate organ system function:
o Haematological (transfusion and/or growth factor support within 2 weeks are not permitted for the purpose of meeting eligibility criteria):
- Absolute neutrophil greater than or equal to 1.0x10^9/L
- Haemoglobin greater than or equal to 80g/L
- Platelet greater than or equal to 50x10^9/L
o Hepatic:
- ALT less than 2.5xULN
- Bilirubin unless than 1.5xULN (Isolated bilirubin greater than or equal to 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%)
o Renal:
- eGFR greater than 30ml/min
- Spot urine (albumin/creatinine ratios) less than 500 mg/g (56 mg/mmol)
o Cardiac:
- LVEF greater than 45%
7. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1% per year), preferably with low user dependency (as described in Appendix 6), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention.

The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
Non-childbearing potential is defined as follows (by other than medical reasons):
- greater than or equal to 45 years of age and has not had menses for greater than 1 year.
- Patients who have been amenorrhoeic for less than 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.
? - Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
8. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:
- Refrain from donating sperm.
PLUS either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
- Must agree to use contraception/barrier as detailed below:
Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of less than 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).
9. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be equal to Grade 1 at the time of enrolment except for alopecia.
10. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.