Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-14)
- Conditions
- Health Condition 1: - Health Condition 2: D758- Other specified diseases of bloodand blood-forming organsHealth Condition 3: D758- Other specified diseases of bloodand blood-forming organs
- Registration Number
- CTRI/2022/05/042713
- Lead Sponsor
- GlaxoSmithKline Research Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
18 or older, capable of giving signed informed consent
ECOG Performance Status 0-2
Histologically or cytologically confirmed diagnosis of: Multiple Myeloma as defined according to IMWG, 2014 criteria [Rajkumar, 2014], and:
Has undergone autologous stem cell transplant ( >100 days), or is considered transplant ineligible,
Has received at least 3 prior lines, including an anti-CD38 antibody and is refractory to an immunomodulatory agent and a proteasome inhibitor
Must have measurable disease
Serum M-protein >=0.5 g/dL (>=5 g/L), or
Urine M-protein >=200 mg/24h, or
Serum Free Light Chain (FLC) assay: Involved serum FLC level >=5 mg/dL (>=50 mg/L) and an abnormal serum FLC ratio ( <0.26 or >1.65) or
Prior treatment-related toxicities must be <= Grade 1, except for alopecia and Grade 2 neuropathy (CTCAE, V5)
Life expectancy of at least 6 months
Sex and Contraception/Barrier Requirements:
Female: Unless not a WOCBP, use highly effective contraceptive method (failure rate of <1% per year), preferably with low user dependency. During intervention & 4 months after last dose
Male: Be abstinent from heterosexual intercourse OR agree to use a male condom and female partner to use an additional highly effective contraceptive method throughout study treatment including the 6-month follow-up period even if they have undergone a successful vasectomy
Symptomatic amyloidosis, active POEMS syndrome, active plasma cell leukemia
Corneal epithelial disease, except nonconfluent superficial punctate keratitis
Evidence of active mucosal or internal bleeding
Presence of renal or liver condition, active infection requiring treatment, serious or unstable medical conditions, other malignancies, protocol-defined cardiovascular risk/disease, pregnancy/lactation (female), recent major surgery
Presence of HIV, Hepatitis B, Hepatitis C (as per protocol requirements)
Prior therapy with:
Systemic MM treatment <= 14 days or 5 half-lives, whichever is shorter
Steroids (equivalent to >= 60 mg prednisone daily for >=4 days) within 14 days
BCMA-targeted therapy, or Hypersensitivity to study treatment
Investigational drug (<= 14 days or 5 half-lives), monoclonal antibody (<= 30 days), any ADC
Plasmapheresis within 7 days of first dose
Anti-MM mAb within 30 days of first dose
Allogenic stem cell transplant (syngeneic transplant will be allowed if no GVHD)
Inadequate bone marrow reserve or organ functions as demonstrated by any of the following:
Absolute neutrophil count <1.0Ã?109/L
Hemoglobin <8 g/dL
Platelet count <50Ã?109/L
Spot urine (albumin/creatinine ratio) >500 mg/g (56 mg/mmol)
eGFR <30mL/min/1.73 m2 (as calculated by Modified Diet in Renal Disease equation)
Note: Laboratory results obtained during screening must be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the participant and the subsequent within range screening result may be used to confirm eligibility.
Note: Supportive care as needed, including transfusion of blood products or growth factors, prior to or during the study is allowed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of Grade â?¥2 ocular AEs according to KVA scale is primary endpoint calculated as the percentage of participants with Grade â?¥2 ocular AEs assessed by KVA scale. <br/ ><br>Incidence rate of ocular AEs by grade (KVA scale). <br/ ><br>Exposure-adjusted incidence Median duration of dose delay. <br/ ><br>% of participants requiring dose. <br/ ><br>% of participants requiring dose delay <br/ ><br>% of participants requiring study treatment discontinuationTimepoint: Incidence rate of Grade â?¥2 ocular AEs according to the KVA scale is the primary endpoint. <br/ ><br>It is calculated as the percentage of participants with Grade â?¥2 ocular AEs assessed by KVA scale.
- Secondary Outcome Measures
Name Time Method To further evaluate the ocular safety and <br/ ><br>tolerability of single-agent belantamab mafodotin in all armsTimepoint: Cumulative event rate of ocular AEs to Week 16 (KVA scale. Incidence rate of ocular AEs by grade (KVA Scale). Exposure-adjusted incidence rate of ocular AE by grade (KVA scale). Median duration of dose delay. Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to ocular AEs (KVA scale). Cumulative incidence of ocular AEs by grade (KVA scale). Toxicity Index by assessment/visit. Duration of ocular AEs (KVA scale)