Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.
Interventions
DRUGCevostamab
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
DRUGXmAb24306
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
DRUGTocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody. * Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy. * Measurable disease, as defined by the protocol * Participants agree to follow contraception or abstinence requirements as defined in the protocol
Exclusion criteria
* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol * Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment * Participants with prior allogeneic SCT or solid organ transplantation * Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Active or history of autoimmune disease * Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM) * Significant cardiovascular disease * Participants with known clinically significant liver disease * Symptomatic active pulmonary disease requiring supplemental oxygen * Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration * Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment * Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 3 years | Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of XmAb24306 | Up to approximately 3 years | — |
| Serum Concentration of Cevostamab | Up to approximately 3 years | — |
| Rate of Complete Response (CR)/ Stringent Complete Response (sCR) | Up to approximately 3 years | Rate of CR/sCR will be determined by the investigator. |
| Rate of Very Good Partial Response (VGPR) | Up to approximately 3 years | Rate of VGPR will be determined by the investigator. |
| Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab | Up to approximately 3 years | — |
| Objective Response Rate (ORR) | Up to approximately 3 years | ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria. |
Countries
Australia, Denmark, Greece, Israel, Norway, South Korea, Spain
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed