myeloma multiple MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BLENREP
Product Name: Belantamab mafodotina
Product Code: GSK2857916
Pharmaceutical Form: Injection/infusion
INN or Proposed INN: Belantamab mafodotin
CAS Number: Belantamab
Current Sponso
Sponsors
Fundación Pethema
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant must be able to understand the study procedures -Patient is willing and able to comply with the protocol requirements. -Patient has given voluntary written informed consent -Relapse multiple myeloma patients that have received at least 1 and no more than 3 prior lines of therapy. -Patients must be refractory to 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 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. -Participant must have an (ECOG) performance status of = 2 -Participant must be = 18 years of age -Participant must have adequate organ function -Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception -Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception -All prior treatment-related toxicities must be = Grade 1 at the time of enrolment except for alopecia -Participant must be able to understand the study procedures and agree to participate by providing written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 -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 -Participant has used an investigational drug within 14 days or five half-lives, -Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drug. -Participant has received prior treatment with anti-BCMA agents. -Received plasmapheresis within 7 days prior to the first dose of study drug. -Participant has received prior radiotherapy within 2 weeks of start of study therapy. -Participant has a known hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. -Participant has a hypersensitivity reaction or idiosyncrasy to other molecular antibodies. -Major surgery = 4 weeks prior to initiating protocol therapy. -Participant has current corneal epithelial disease -Participant has peripheral neuropathy or neuropathic pain grade =2 -Participant evidence of cardiovascular risk including any of the following: • QTcF interval QTcF > 480 msec • Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree AV block. • History of myocardial infarction, acute coronary syndromes, coronary angioplasty, or stenting or bypass grafting within six months of Screening. • Class III or IV heart failure • Uncontrolled hypertension -Participant has current unstable liver or biliary disease -Presence of active renal condition. -Evidence of active mucosal or internal bleeding. -Use of contact lenses -Any serious medical condition or psychiatric illness -Uncontrolled endocrine diseases -Acute diffuse infiltrative pulmonary disease and/or pericardial disease. -severe chronic obstructive pulmonary disease or asthma -History of interstitial lung disease -An active infection requiring antibiotic, antiviral, or antifungal treatment - HIV infection -hepatitis B surface antigen, or hepatitis B core or within 3 months prior to first dose of study treatment. -positive hepatitis C antibody test result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Lead-in phase -To determine the maximum tolerated dose, and the recommended phase 2 dose of belantamab mafodotin in combination with carfilzomib and dexamethasone. Expansion phase -To evaluate the efficacy in terms of complete response rate and rates of minimal residual negativity after 12 months of therapy -To evaluate safety and tolerability of the combination.;Secondary Objective: -To determine time to event data of the combinations: Progression-free survival, progression-free survival at 12 months, duration of response, time to response, and overall survival. -Evaluate deepening of response during continuous therapy at 12, and 24 months. -Evaluate sustained MRD rate at 1 and 2 years. -Evaluate the rate of conversion from MRD positivity to MRD negativity during the treatment. -To assess the safety of the combination of belantamab mafodotin + Kd, as well as the incidence of corneal and ophthalmologic adverse events.;Primary end point(s): This is a study aiming to determine the MTD and the recommended phase 2 dose of belantamab mafodotin in combination with carfilzomib-dexamethasone in the phase 1. Once the MTD will be defined, the clinical efficacy, safety and tolerability of the combination will be evaluated in terms of CR and MRD negativity in the phase 2.;Timepoint(s) of evaluation of this end point: The duration of the patient inclusion period will be approximately 21 months and the treatment time for each patient is estimated at 12 months. The follow-up period, once you finish the study treatment, will be approximately 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To determine Time to event data of the after treatment with the combination of belantamab mafodotin plus carfilzomib and dexamethasone in relapsed myeloma patients, refractory to lenalidomide and treated with 1 up to 3 prior lines of therapy. -Evaluate deepening of response during continuous therapy at 12, and 24 months. -Evaluate sustained MRD rate at 12, 18 and 24 months. -Evaluate the rate of conversion from MRD positivity to MRD negativity from months 12 onwards (yearly). -To calculate safety of the combination, as well as the incidence of corneal and ophthalmologic adverse events.;Timepoint(s) of evaluation of this end point: The duration of the patient inclusion period will be approximately 21 months and the treatment time for each patient is estimated at 12 months. The follow-up period, once you finish the study treatment, will be approximately 48 months | — |
Countries
Spain
Contacts
Public ContactDr. Juan José Lahuerta Palacios
Fundación Pethema
Outcome results
None listed