Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patien… (NCT05060627) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
Spain60 participantsStarted 2021-12-20
Plain-language summary
This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients.
Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
✓. Patient has given voluntary written informed consent before performance of any study-related procedure nor part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
✓. Relapse multiple myeloma patients that have received at least 1 and no more than 3 prior lines of therapy. Induction, intensification with high-dose melphalan and stem cell transplant and maintenance is considered one line of treatment.
✓. Patients must be refractory to lenalidomide. Refractoriness is defined as progression while receiving lenalidomide or in the first 60 days after the last dose of lenalidomide.
✓. Patients can have received prior treatment with proteasome inhibitors. Patients with prior bortezomib treatment are eligible regardless of refractory status. Prior carfilzomib treatment is allowed, provided that the patients achieve at least a partial response to prior carfilzomib, and that there is a treatment free interval of at least 6 months.
✓. Participant must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/L (100 mg/dl), with an abnormal serum FLC ratio.
What they're measuring
1
Number of participants with adverse events (AEs) during the triplet-therapy in phase I.
Timeframe: At the end of the first 4-week cycle following a 3+3 design.
2
Overall Response Rate (ORR)
Timeframe: 12 months.
3
Minimal Residual Disease (MRD) negativity rate
Timeframe: At the time of CR/VGPR, and in all patients at month 12, 18, and 24, and yearly thereafter.
4
Complete Response Rate (CRR)
Timeframe: 12 months.
5
Incidence of deaths and primary cause of death.
Timeframe: Throughout the study. Approximately 60 months.
6
Incidence of adverse events (AEs).
Timeframe: Throughout the study. Approximately 60 months.
7
% of patients with changes in hematologic laboratory parameters
Timeframe: Throughout the study. Approximately 60 months.
8
% of patients with changes in blood chemistry laboratory parameters
✓. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
✓. Participant must be ≥ 18 years of age
Exclusion criteria
✕. Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia or active POEMS syndrome at the time of screening.
✕. Participant has invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
✕. Participant has meningeal involvement of multiple myeloma.
✕. Pregnant or breastfeeding females.
✕. Participant is simultaneously enrolled in other interventional clinical trial.
✕. Participant has used a systemic anti-myeloma drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
✕. Participant has used an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
✕. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drug.
Timeframe: Throughout the study. Approximately 60 months.
9
Frequency of ocular findings on ophthalmic exam
Timeframe: Throughout the study. Approximately 60 months.