Carfilzomib for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- Active MM or SMM which is untreated\n- At least 18 years of age, with at least 6 months of expected survival\n- Active MM or SMM (defined as measurable M spike OR pathological FLC ratio AND bone marrow PC% > 10%) which is untreated\n- Laboratory values, see protocol\n- Prior therapy for the treatment of solitary plasmacytoma is permitted, but >7 days should have elapsed from the last day of radiation.\n- Measurable disease as defined by at least ONE of the following: Serum monoclonal protein >1.0 g/L, >200 mg of monoclonal protein in the urine on 24 hour electrophoresis , Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n- ECOG performance status (PS) 0, 1 or 2\n- Provide informed written consent\n- Negative pregnancy test done ≤7 days prior to entry, for women of childbearing potential only\n- Willing to follow strict birth control measures as outlined in the protocol\n- Patients must be willing and able to adhere to the study schedule and other protocol requirement"}

Exclusion criteria

• {"criterion_text":"- MGUS or low risk smoldering myeloma\n- Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease\n- Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception\n- Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease\n- Other concurrent chemotherapy, or any ancillary therapy considered investigational\n- Peripheral neuropathy > Grade 3 on clinical examination or grade 2 with pain within 30 days prior to C1D1\n- Major surgery ≤14 days prior to C1D1\n- Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months\n- Known human immunodeficiency virus (HIV) positive\n- Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection\n- Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol\n- Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products\n- Inability to comply with protocol/procedures"}

Primary endpoints

• {"endpoint_text":"- Primary: Proportion of participants diagnosed with intermediate or high risk SMM that have MRD negativity three year from study enrollment","definition_or_measurement_approach":"Primary objective stated as determining MRD negativity rate three years after study enrollment; measurement approach for MRD not specified in the CTIS data provided."}

Secondary endpoints

• {"endpoint_text":"- Clinical response by IMWG\n- Clinical outcomes by IMWG\n- Safety\n- Correlation with correlative and clinical outcomes","definition_or_measurement_approach":"Clinical response by IMWG: assessed per IMWG criteria (as stated). Clinical outcomes by IMWG: includes outcomes such as progression-free survival and overall survival (secondary objectives mention PFS and OS). Safety: rate of adverse events/toxicities. Correlation with correlative and clinical outcomes: exploratory analyses correlating biomarkers/correlative work with clinical outcomes."}

Iceland

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

11-12-2024

Processing Time Days

9

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Landspitali

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Iceland