Study of safety, tolerability, and MTD/RD of WVT078 in patients with relapsed and/or refractory multiple myeloma

JRCT ID: jRCT2080225301

Registered date:04/08/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 18/09/2020
• Target sample size: 41
• Countries of recruitment: Japan,North America,Europe,Oceania
• Study type: Interventional

Intervention(s)

ArmA : WVT078
ArmB : WVT078 in combination with WHG626

Outcome(s)

Primary Outcome

- Incidence and severity of DLTs, AEs and SAEs, including changes in lab values, physical exams (PEs), ECGs
- Frequency of dose interruptions, discontinuations and reductions

Key inclusion & exclusion criteria

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

Include criteria

- Subjects with a confirmed diagnosis of multiple myeloma who have received two or more standard of care (SoC) regimens including an IMiD, a proteasome inhibitor, and an anti-CD38 agent and are relapsed and/or refractory to or intolerant of each regimen (if available), with documented evidence of disease progression per IMWG criteria, and must not be eligible for treatment with other regimens known to provide clinical benefit, as determined by the investigator. Subjects who have received a prior autologous bone marrow transplant, a BCMA CAR-T, or BCMA ADC therapy, and otherwise meet the inclusion criteria are eligible for this study.
- Must have measurable disease defined by at least 1 of the following 3 measurements:
- Serum M-protein => 1.0 g/dL or
- Urine M-protein => 200 mg/24 hours or
- Serum free light chain (sFLC) > 100 mg/L of involved FLC

Exclude criteria

- History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients
- Subjects with toxicity to prior BCMA targeted agents
- Malignant disease, other than that being treated in this study
- Active, known or suspected autoimmune disease
- Subjects who are currently receiving treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment
- Patients with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Impaired cardiac function or clinically significant cardiac disease

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT04123418,JapicCTI-205397