REST - Replacing Steroids in the Transplant Ineligble

Korábbi kezelés

• 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.
• 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).

Más betegség

• Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positivity.
• 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.
• No active malignancy with a lower life expectancy than myeloma.
• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.

Laborértékek

• Female patients who are lactating or have a positive serum pregnancy test during the screening period.

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Voluntary written informed consent.
• Participant must be >18 years of age at the time of signing the informed consent.
• Newly diagnosed multiple myeloma (IMWG criteria) in-eligible for high-dose therapy and ASCT.
• Measurable disease as defined by the International Myeloma Working Group:
  • Serum monoclonal paraprotein (M-protein) level > 10 g/L or urine M-protein level >200 mg/24 hours; or
  • 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.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can only be enrolled if caused by myeloma.
• Clinical laboratory values meeting the following criteria during the Screening Phase:
  • 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
  • Adequate renal function:
  • eGFR>30 mL/min/m2
• Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements.
• 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.
• 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.