JOURNAL ONKOLOGIE – STUDIE

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: CAEL-101 combined with SoC plasma cell dyscrasia
  CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. As this is an event driven study, the study will continue, and all patients will continue to receive study treatment until at least 54 deaths have been observed.
• Placebo Comparator: Placebo combined with SoC plasma cell dyscrasia
  Patients randomized to receive placebo will receive 0.9% normal saline in an equivalent volume to a CAEL-101 infusion (approximately 250 cc). The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. As this is an event driven study, the study will continue, and all patients will continue to receive study treatment until at least 54 deaths have been observed.
• Other: Concurrent Plasma Cell Dyscrasia Treatment
  All patients will also receive concurrent treatment for Plasma Cell Dyscrasia (PCD) with CyBorD according to institutional SoC. Patients should initiate their CyBorD chemotherapy regimen within 7 days of receiving the first dose of study drug. It is the intent of this protocol that patients will receive CyBorD per institution SoC in the study, as long as they are tolerating it. However, after two cycles of CyBorD, if the patient is not benefiting from or tolerating CyBorD in the Investigator's judgement, the investigator may change the CyBorD regimen or stop it.

Geprüfte Regime

• CAEL-101:
  The investigational product, CAEL-101, is formulated as a sterile liquid solution of protein plus excipients for dilution in a single-use, stoppered, glass vial. Each 10 mL vial contains 300 mg of CAEL-101 at a concentration of 30 mg/mL. CAEL-101 will be diluted with commercially available 0.9% Normal Saline.
• Placebo:
  Commercially available 0.9% Normal Saline will be used as the placebo.
• cyclophosphamide, bortezomib, and Dexamethasone (CyBorD):
  According to institutional standard of care.

Quelle: ClinicalTrials.gov