Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients

Inclusion Criteria:

1. Participant must have Newly diagnosed multiple myeloma. Newly diagnosed subjectsmust have symptomatic disease following the IMWG updated criteria (Rajkumar Lancet 2014, Appendix 6).

2. Participant must have a measurable secretory disease defined as either serummonoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200mg/24h.For patients whose disease is only measurable by serum FLC, the involvedFLC should be ≥ 10mg/L (100 mg/dl), with an abnormal serum FLC ratio.

3. Newly diagnosed participants must be eligible for stem cell transplant atinvestigator criteria.

4. Participant must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of ≤ 2

5. Participant must be ≥ 18 years of age

6. Participant must have adequate organ function, defined as follows: System Laboratory Values Hematologic Absolute neutrophil count (ANC) ≥1.5 X 109/LHemoglobin ≥8.0 g/dL Platelets ≥75 x 109/L for subjects in whom <50% of bone marrownucleated cells are plasma cells; otherwise platelet count >50 × 109/L Calciumcorrected serum calcium <14 mg/dL (<3.5 mmol/L); or free ionized calcium <6.5 mg/dL (<1.6 mmol/L); Hepatic Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN isacceptable if bilirubin is fractionated and direct bilirubin <35%) ALT ≤2.5 X ULNAST ≤2.5 X ULN Renal eGFRa ≥30 mL/min/ 1.73 m2 Spot urine (albumin/creatinine ratios (spot urine) <500 mg/g (56 mg/mmol)

7. Female participants: contraceptive use should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant orbreastfeeding, 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 afailure rate of <1% per year), preferably with low user dependency, during theintervention period and for at least 4 months after the last dose of studyintervention and agrees not to donate eggs (ova, oocytes) for the purpose ofreproduction during this period. The investigator should evaluate theeffectiveness of the contraceptive method in relationship to the first dose ofstudy intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required bylocal regulations) within 72 hours before the first dose of study intervention andagree to use a highly effective method of contraception during the study and for 4months after the last dose of belantamab mafodotin. Additional requirements forpregnancy testing during and after study intervention The investigator isresponsible for review of medical history, menstrual history, and recent sexualactivity to decrease the risk for inclusion of a woman with a nearly undetectedpregnancy. Nonchildbearing potential is defined as follows (by other than medical reasons):

• ≥45 years of age and has not had menses for >1 year

• Patients who have been amenorrhoeic for <2 years without history of ahysterectomy and oophorectomy must have a follicle stimulating hormone value inthe postmenopausal range upon screening evaluation Post-hysterectomy,post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy oroophorectomy must be confirmed with medical records of the actual procedure orconfirmed by an ultrasound. Tubal ligation must be confirmed with medicalrecords of the actual procedure.

8. Male participants: contraceptive use should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following duringthe intervention period and for at least 6 months:

• Refrain from donating sperm PLUS either:

• Be abstinent from heterosexual intercourse as their preferred and usuallifestyle (abstinent on a long term and persistent basis) and agree to remainabstinent. OR

• Must agree to use contraception/barrier as detailed below: Agree to use a male condom and female partner to use an additional highly effectivecontraceptive method with a failure rate of <1% per year as when having sexualintercourse with a woman of childbearing potential (including pregnant females). Allprior treatment-related toxicities (defined by National Cancer Institute- CommonToxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 (must be ≤ Grade 1 atthe time of enrolment except for alopecia).

9. Participant must be able to understand the study procedures and agree to participatein the study by providing written informed consent.

Exclusion Criteria:

Patients that present any of the following exclusion criteria cannot be included in the trial:

1. Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy ofundetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cellleukemia or active POEMS syndrome at the time of screening.

2. Participant has malignancies other than disease under study, except for any othermalignancy from which the participant has been disease-free for more than 2 yearsand, in the opinion of the principal investigators, will not affect the evaluationof the effects of this clinical trial treatment on the currently targetedmalignancy. Participants with curatively treated non-melanoma skin cancer may beenrolled.

3. Participant has meningeal involvement of multiple myeloma.

4. Pregnant or breastfeeding females.

5. Participant is simultaneously enrolled in other interventional clinical trial.

6. Participant must has used an investigational drug within 14 days or five half-lives,whichever is shorter, preceding the first dose of study drug.

7. Participant has used of any anti-myeloma drug therapy, except for steroid pulses incase of emergency (40 mg of dexamethasone for 4 days), the administration ofbisphosphonates or antialgic radiotherapy or due to the presence of plasmacytomasrequiring some emergency.

8. Participant who have received prior treatment with a monoclonal antibody within 30days of receiving the first dose of study drugs.

9. Participant has a known immediate or delayed hypersensitivity reaction oridiosyncrasy to drugs chemically related to: belantamab mafodotin, lenalidomide,boronic acid (bortezomib), dexamethasone or any of the components of the studytreatment.

10. Participant who have had major surgery ≤ 4 weeks prior to initiating protocoltherapy.

11. Participant who have current corneal epithelial disease except mild punctatekeratopathy

12. Participant has peripheral neuropathy or neuropathic pain grade ≥2, as defined bythe National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE)Version 4.0 (APPENDIX 4).

13. Participant is unable or unwilling to undergone antithrombotic prophylactictreatment

14. Participant evidence of cardiovascular risk including any of the following:

• Evidence of current clinically significant uncontrolled arrhythmias, includingclinically significant ECG abnormalities such as 2nd degree (Type II) or 3rddegree atrioventricular (AV) block.

• History of myocardial infarction, acute coronary syndromes (including unstableangina), coronary angioplasty, or stenting or bypass grafting within threemonths of Screening.

• Class III or IV heart failure as defined by the New York Heart Associationfunctional classification system [NYHA, 1994]

• Uncontrolled hypertension

15. Incidence of gastrointestinal disease that may significantly alter the absorption ofLenalidomide.

16. Participant must not have current unstable liver or biliary disease defined by thepresence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal orgastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liverdisease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliaryinvolvement of malignancy is acceptable if otherwise meets entry criteria

17. Presence of active renal condition (infection, requirement for dialysis or any othercondition that could affect patient's safety). Participants with isolatedproteinuria resulting from MM are eligible, provided they fulfil inclusion criteria

18. Participant who use contact lenses while participating in this study, except ifcontact lenses are removed during participation in the study

19. Participant who have had plasmapheresis within 7 days prior to first dose of studytreatment.

20. Evidence of active mucosal or internal bleeding.

21. Any serious medical condition or psychiatric illness that would interfere inunderstanding of the informed consent form.

22. Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism orhyperthyroidism) (i.e. requiring relevant changes in medication within the lastmonth, or hospital admission within the last 3 months).

23. Patients with acute diffuse infiltrative pulmonary disease and/or pericardialdisease.

24. Patients with severe chronic obstructive pulmonary disease (COPD) or asthma withforced expiratory volume in the first minute (FEV1) less than 50%.

25. The subject is seropositive for human immunodeficiency virus (HIV) or presence ofactive hepatitis B infection (documented by a positive test for hepatitis B surfaceantigen [HBsAg], or hepatitis C (documented by a positive test for the surfaceantigen of hepatitis C [HCsAg] or positive quantification of HCV RNA Note:Participants with positive Hepatitis C antibody due to prior resolved disease can beenrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.

Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.