A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (CAMMA 1)

JRCT ID: jRCT2031230660

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 23/05/2024
• Target sample size: 184
• Countries of recruitment: CZECH REPUBLIC,Japan,KOREA REPUBLIC OF,Japan,ISRAEL,Japan,ITALY,Japan,UNITED KINGDOM,Japan,SPAIN,Japan,DENMARK,Japan,POLAND,Japan,FRANCE,Japan,AUSTRALIA,Japan,CANADA,Japan,UNITED STATES,Japan
• Study type: Interventional

Intervention(s)

cevostamab: Cevostamab will be administered intravenously in 28-day cycles Q2W followed by Q4W .Participants can be treated until disease progression or unacceptable toxicity.
Tocilizumab: Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Pomalidomide: Pomalidomide will be administered orally (PO) on a 28-day cycle.
Dexamethasone: Dexamethasone will be administered via IV or orally at 20 mg.

Outcome(s)

Primary Outcome

safety. efficacy, phamacokinetics
-Observation/Inspection
-Adverse events; NCI CTCAE v5.0, ASTCT Consensus Grading
-Response Rates; International Myeloma Working Group (IMWG) Criteria

Secondary Outcome

exploratory, phamacokinetics, other
-Observation/Inspection
-Exporatory; PRO-CTCAE, EORTC item library
-Immunogenicity; anti-drug Abs (ADAs) of RO718779

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants with R/R MM who have received at least 1 prior line of treatment
-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-Measurable disease
-Agreement to provide bone marrow biopsy and aspirate samples
-Resolution of adverse events from prior anti-cancer therapy to Grade <=1
-Meet the other eligibility criteria as defined in the protocol.

Exclude criteria

-Inability to comply with protocol-mandated hospitalization and activities restrictions
-Prior allogeneic SCT
-Circulating plasma cell count exceeding 500/uL or 5% of the peripheral blood white cells
-History of other malignancy within 2 years before screening
-Positive and quantifiable EBV PCR or CMV PCR before first study treatment
-Significant cardiovascular disease
-Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
-Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment
-Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment
-Treatment with radiotherapy within 4 weeks (systemic) or 14 days (focal) before first study treatment
-Treatment with any chemotherapeutic agent or other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
-ASCT within 100 days before first study treatment
-Meet the other exclusion criteria as defined in the protocol

Related Information

• Primary Sponsor: Tina Nielsen
• Secondary ID(s): NCT04910568