Multiple Myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Venclyxto
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VENETOCLAX
CAS Number: 1257044-40-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration numbe
Sponsors
Department of Internal Medicine Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, age 18 years or older; • A prior diagnosis of multiple myeloma; • At least one prior line of therapy; • The presence of t(11;14) by fluorescent in situ hybridization • Relapsed or refractory disease defined as o progressive disease ? during treatment with the last line of therapy or ? within 60 days after the last line of therapy or o minimal response or better not achieved after completion of at least two cycles of the last line of therapy • Measurable disease defined as any of the following: o Serum monoclonal protein = 10 g/L by serum protein electrophoresis o = 200 mg of monoclonal protein in the urine on 24-hour electrophoresis o Serum free light chain = 100 mg/L and abnormal serum kappa to lambda free light chain (FLC) ratio • Life expectancy of = 6 months; • ECOG performance status = 2. (Patients with performance status > 2 based solely on bone pain secondary to multiple myeloma may be eligible following approval of the sponsor); • A negative serum or urine pregnancy test if the subject is a female of childbearing potential, defined as any sexually mature female who: o has not undergone a hysterectomy or bilateral oophorectomy and o has not been naturally postmenopausal for at least 24 consecutive months ? A sexually mature female who stopped having menstrual cycles due to cancer therapy cannot be considered naturally postmenopausal • Patient agrees to practice appropriate methods of birth control; • Ability to understand the purpose and risks of the study and provide signed and dated informed consent; • Adequate organ function with the following laboratory results: o Absolute neutrophil count = 1,000 cells/mm3 (1.0 x 109/L) o Platelet count = 30,000 cells/ mm3 (30 x 109/L) (without transfusions required within 10 days prior to initiation of study treatment) o Hemoglobin = 5 mmol/l; red blood cell transfusions and treatment with erythropoietin are permitted o Total Bilirubin = 1.5 x upper limit of normal, except patients diagnosed with Gilbert’s syndrome that have been approved by the sponsor o Alanine transaminase = 3.0 x upper limit of normal o Renal function: Estimated creatinine clearance by Cockcroft- Gault formula of = 30 mL/min 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Any somatic or psychiatric condition that in the investigator’s opinion would impose excessive risk to the patient or would adversely affect the patient’s participation in this study; • Severe ongoing infection that in the investigator’s opinion would impose excessive risk to the patient • Known intolerance to the study treatment; • Pregnant or breast-feeding females; • Known human immunodeficiency virus or active hepatitis B or C viral infection; • The use of live vaccines within 30 days before initiation of study treatment; • Autologous stem cell transplant within 12 weeks prior to initiation of study treatment; • Prior allogeneic stem cell transplantation with active graft-versus-host-disease; • = Grade 3 cardiac conduction system abnormalities unless patient has a pacemaker • Cardiovascular disability status of New York Heart Association Class greater than or equal to 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Overall response rate;Secondary Objective: Secondary end-points •Progression-free survival •Clinical benefit rate •Time to next treatment •Overall survival •Time to response •Duration of response •Safety and tolerability •Discontinuation rate •Quality of life •Number of serious adverse events due to infections •Duration of hospital admissions due to infections Exploratory end-points •Estimation of humoral immunodeficiency of subjects at baseline by measuring serum anti-pneumococcal polysaccharide IgG, IgA, IgM antibodies •Assessment of the relation of humoral immunodeficiency to infections •Assessment of pneumococcal vaccination response and its relation to infections •Estimation of Bcl-2 overexpression by immunohistochemistry •Assessment of the relation of Bcl-2 overexpression to the efficacy of the study treatment ;Primary end point(s): Overall response rate;Timepoint(s) of evaluation of this end point: At achievement of best response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points • Progression-free survival • Clinical benefit rate • Time to next treatment • Overall survival • Time to response • Duration of response • Safety and tolerability • Discontinuation rate • Quality of life • Number of serious adverse events due to infections • Duration of hospital admissions due to infections Exploratory end-points • Estimation of humoral immunodeficiency of subjects at baseline by measuring serum anti-pneumococcal polysaccharide IgG, IgA, IgM antibodies • Assessment of the relation of humoral immunodeficiency to infections • Assessment of pneumococcal vaccination response and its relation to infections • Estimation of Bcl-2 overexpression by immunohistochemistry • Assessment of the relation of Bcl-2 overexpression to the efficacy of the study treatment ;Timepoint(s) of evaluation of this end point: When the relevant events occur. | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Clinical Trial Unit, Department of Internal Medicine, Section of Hematology, Vejle Hospital
Outcome results
None listed