A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
NCT05714839 · Phase 1, Phase 2 · Bullhead City, Arizona, United States
- Condition
- Multiple Myeloma
- Disease stage
- Stage I-IV
- Phase
- Phase 1, Phase 2
- Study type
- DRUG
- Intervention
- Belantamab, Belantamab mafodotin, Pomalidomide, Dexamethasone
- Age
- 18 Years to
- Gender
- All
- Sponsor
- GlaxoSmithKline
- Research institution
- GlaxoSmithKline
- Facility
- GSK Investigational Site
- Research center
- GSK Investigational Site
Summary
The study consists of three parts: * Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2: The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of belantamab in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
Inclusion criteria
Inclusion criteria * Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place. * Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG) and have progressed on or following the last line of treatment * Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, including any immunomodulatory drug (IMiDs lenalidomide, pomalidomide or thalidomide), a proteasome inhibitor, and an anti-CD38 monoclonal antibodies (mAb) (either in combination or separately). * Part 3: Have received at least 1 prior line of treatment anti-myeloma treatments, including lenalidomide. Prior anti-CD38-containing regimen is not mandated, however no more than 70% of participants recruited may be anti-CD38 naïve. * Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met: * transplant was greater than (\>)100 days prior to screening. * No active bacterial, viral, or fungal infection(s) present * Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2. * Measurable disease defined as at least ONE of the following: * Serum M-protein concentration greater than or equal to (\>=) 0.5 gram (g)/ deciliter (dL) (\>=5 gram/liter \[g/L\]) * Urine M-protein excretion \>=200 milligram (mg)/24 hours (\>=0.2 g/24 hours) * Serum free light chain (FLC) assay: involved FLC level \>=10 mg/dL (\>=100 milligrams per liter \[mg/L\]) and an abnormal serum FLC ratio (less than \[\<\]0.26 or \>1.65) * Have adequate organ system function as defined by the laboratory assessments * All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], v5.0, 2017) must be Grade less than or equal to (\<=)1 at the time of screening except for alopecia (any grade), neuropathy (Grade \<=2), or endocrinopathy managed with replacement therapy (any grade). * Participants or legally authorized representative (LAR) (if applicable per local regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Male Participants (for parts 1b, 2 and 3): * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male Participants enrolled in part 1 (and expansion) cohort receiving belantamab monotherapy are not required to use contraception * Male participants are eligible to participate in parts 2 and 3 if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm: * Refrain from donating fresh unwashed semen 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 \<1 percent (%) per year when having sexual intercourse with POCBP who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females. * 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 Participant of child-bearing potential (POCBP) or * Is a POCBP and using a contraceptive method that is highly effective (with a failure rate of \<1%
Primary outcomes
Parts 1, 2 and 3: Number of Participants with any Adverse Event; Part 1 (Dose escalation cohort) and Part 2: Number of Participants with Dose Limiting Toxicities (DLTs); Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters
Secondary outcomes
Part 1: Overall Response Rate (ORR); Part 1: Observed Plasma Concentration of belantamab; Part 1: Area Under the Curve (AUC) of belantamab