臨床研究等提出・公開システム

AN OPEN-LABEL, MULTICENTER, PHASE Ib TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF CEVOSTAMAB AS MONOTHERAPY AND CEVOSTAMAB PLUS POMALIDOMIDE AND DEXAMETHASONE OR CEVOSTAMAB PLUS DARATUMUMAB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED OR

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

Tina Nielsen

F. Hoffmann-La Roche

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Mar. 29, 2024

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

-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.

-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

Both

Multiple Myeloma

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.

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

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

+81-3-3520-0111

Feb. 06, 2024

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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