Venetoclax for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- •\tMale or female, age 18 years or older\n- •\tFemale patients must agree to practice highly effective method of birth control until at least 30 days after the last dose of study treatment. Highly effective method of birth control is defined as the combination of both a hormonal and a barrier method of contraception\n- •\tAbility to understand the purpose and risks of the study and provide signed and dated informed consent;\n- •\tAdequate organ function with the following laboratory results: o\tAbsolute neutrophil count ≥ 1,000 cells/mm3 (1.0 x 109/L) o\tPlatelet count ≥ 30,000 cells/ mm3 (30 x 109/L) (without transfusions required within 10 days prior to initiation of study treatment) o\tHemoglobin ≥ 5 mmol/l; red blood cell transfusions and treatment with erythropoietin are permitted o\tTotal Bilirubin ≤ 1.5 x upper limit of normal, except patients diagnosed with Gilbert’s syndrome that have been approved by the sponsor o\tAlanine transaminase ≤ 3.0 x upper limit of normal o\tRenal function: Estimated creatinine clearance by Cockcroft- Gault formula of ≥ 30 mL/min\n- •\tA prior diagnosis of multiple myeloma\n- •\tAt least one prior line of therapy\n- •\tThe presence of t(11;14) by fluorescent in situ hybridization\n- •\tRelapsed or refractory disease defined as o\tprogressive disease \tduring treatment with the last line of therapy or \twithin 60 days after the last line of therapy or o\tminimal response or better not achieved after completion of at least two cycles of the last line of therapy\n- •\tMeasurable disease defined as any of the following: o\tSerum monoclonal protein ≥ 10 g/L by serum protein electrophoresis o\t ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis o\tSerum free light chain ≥ 100 mg/L and abnormal serum kappa to lambda free light chain (FLC) ratio\n- •\tLife expectancy of ≥ 6 months\n- •\tECOG 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);\n- •\tA negative serum or urine pregnancy test if the subject is a female of childbearing potential, defined as any sexually mature female who: o\thas not undergone a hysterectomy or bilateral oophorectomy and o\thas not been naturally postmenopausal for at least 24 consecutive months \tA sexually mature female who stopped having menstrual cycles due to cancer therapy cannot be considered naturally postmenopausal"}

Exclusion criteria

• {"criterion_text":"- •\tAny 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\n- •\tCardiovascular disability status of New York Heart Association Class greater than or equal to 3\n- •\tSevere ongoing infection that in the investigator’s opinion would impose excessive risk to the patient\n- •\tKnown intolerance to the study treatment\n- •\tPregnant or breast-feeding females\n- •\tKnown human immunodeficiency virus or active hepatitis B or C viral infection\n- •\tThe use of live vaccines within 30 days before initiation of study treatment\n- •\tAutologous stem cell transplant within 12 weeks prior to initiation of study treatment\n- •\tPrior allogeneic stem cell transplantation with active graft-versus-host-disease\n- •\t≥ Grade 3 cardiac conduction system abnormalities unless patient has a pacemaker"}

Primary endpoints

• {"endpoint_text":"- To evaluate the overall response rate (partial response or better) of the combination of Venetoclax-dexamethasone in patients with relapsed or refractory multiple myeloma","definition_or_measurement_approach":"Overall response rate defined as partial response or better."}

Secondary endpoints

• {"endpoint_text":"- progression-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- clinical benefit rate (minimal response or better)","definition_or_measurement_approach":""}
• {"endpoint_text":"- time to next treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- time to response","definition_or_measurement_approach":""}
• {"endpoint_text":"- duration of response","definition_or_measurement_approach":""}
• {"endpoint_text":"- safety and tolerability","definition_or_measurement_approach":""}
• {"endpoint_text":"- discontinuation rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- quality of life","definition_or_measurement_approach":""}
• {"endpoint_text":"- number of serious adverse events due to infections","definition_or_measurement_approach":""}
• {"endpoint_text":"- duration of hospital admissions due to infections","definition_or_measurement_approach":""}
• {"endpoint_text":"- effect of PET-positivity on efficacy end-points","definition_or_measurement_approach":""}
• {"endpoint_text":"- Estimation of humoral immunodeficiency of subjects at baseline by measuring serum anti-pneumococcal polysaccharide IgG, IgA, IgM antibodies","definition_or_measurement_approach":""}
• {"endpoint_text":"- assessment of the relation of humoral immunodeficiency to infections","definition_or_measurement_approach":""}
• {"endpoint_text":"- assessment of pneumococcal vaccination response and its relation to infections","definition_or_measurement_approach":""}
• {"endpoint_text":"- estimation of Bcl-2 overexpression by immunohistochemistry","definition_or_measurement_approach":""}
• {"endpoint_text":"- assessment of the relation of Bcl-2 overexpression to the efficacy of the study treatment","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

09-01-2025

Processing Time Days

282

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

Lillebaelt Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"codes: 1,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}