ISATUXIMAB for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent.\n- Participant must be >18 years of age at the time of signing the informed consent.\n- Newly diagnosed multiple myeloma (IMWG criteria) in-eligible for high-dose therapy and ASCT.\n- Measurable disease as defined by the International Myeloma Working Group: a. Serum monoclonal paraprotein (M-protein) level > 10 g/L or urine M-protein level >200 mg/24 hours; or b. Light chain multiple myeloma without measurable disease in the serum or the urine: Involved serum immunoglobulin FLC > 100 mg/L and abnormal serum immunoglobulin kappa lambda FLC ratio.\n- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can only be enrolled if caused by myeloma.\n- Clinical laboratory values meeting the following criteria during the Screening Phase: a. Adequate bone marrow function: - Hemoglobin >7,5 g/dL (transfusion is permitted, recombinant human EPO use is permitted, however transfusion is not permitted within 3 days before screening) - Absolute neutrophil count > 1.0 x 109/L (G-CSF use is permitted) - Platelet count >70 x 109/L a) Adequate renal function: - eGFR>30 mL/min/m2\n- Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements.\n- Females of childbearing potential (FCBPs) must have a confirmed negative serum or urine pregnancy test within 10-14 days prior to and again within 24 hours prior to starting study medication.\n- FCBPs and male subjects who are sexually active with FCBP must agree to use highly effective concomitant methods of contraceptive during the intervention period, for at least 5 months after last dose of isatuximab treatment and at least 28 days after last lenalidomide treatment. Male subjects must refrain from donating sperm during this period."}

Exclusion criteria

• {"criterion_text":"- Prior or current systemic therapy for multiple myeloma with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.\n- Radiation therapy for treatment of plasmacytoma(s) within 14 days before treatment (local radiation for pain control or to prevent fracture is allowed within 14 days before treatment).\n- Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positivity.\n- Any other serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.\n- An active malignancy with a lower life expectancy than myeloma.\n- Female patients who are lactating or have a positive serum pregnancy test during the screening period.\n- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent."}

Primary endpoints

• {"endpoint_text":"- The proportion of patients who achieve MRD negativity measured by NGF Euroflow during/or after first 18 Cycles of study treatment.","definition_or_measurement_approach":"Measured by NGF Euroflow during or after the first 18 cycles of study treatment."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients who achieve PR or better after 2 cycles of IVRd followed by 6 cycles of IVR, followed by 10 cycles of IR.","definition_or_measurement_approach":"Response (PR or better) assessed after the specified treatment sequence (no further measurement detail provided)."}
• {"endpoint_text":"- The PFS rate","definition_or_measurement_approach":"Progression-free survival rate (no additional measurement details provided)."}
• {"endpoint_text":"- The OS rate","definition_or_measurement_approach":"Overall survival rate (no additional measurement details provided)."}
• {"endpoint_text":"- The number of AEs and relevant laboratory parameters monitored at every visit (see SoA) from inclusion until end of study.","definition_or_measurement_approach":"Adverse events and laboratory parameters monitored at every visit according to the Schedule of Assessments (SoA) from inclusion until end of study."}
• {"endpoint_text":"- The change in HRQL trajectories and steroid toxicity over time (day 22 – day 1) during IVRd (cycle 1 and 2) compared to IVR (cycle 4 and 5).","definition_or_measurement_approach":"Change in health-related quality of life (HRQL) trajectories and measures of steroid toxicity comparing specified cycles (day 22 – day 1); specific instruments not detailed in provided data."}

Denmark

Earliest CTIS Part Ii Submission Date

19-09-2024

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

551

Number Of Sites

1

Number Of Participants

3

Norway

Earliest CTIS Part Ii Submission Date

19-09-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

552

Number Of Sites

3

Number Of Participants

48

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Health care"}