Multiple Myeloma
Conditions
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (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
DRUGXmAb24306
XmAb24306 will be given via intravenous (IV) infusion
DRUGDaratumumab
Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)
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
* Life expectancy of at least 12 weeks * Measurable disease, as defined by the protocol * 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 * Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment
Exclusion criteria
* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol * Prior allogeneic stem cell or solid organ transplantation * Autologous stem cell transplantation within 100 days prior to initiation of study treatment * Significant cardiovascular disease * Known clinically significant liver disease * Active or history of autoimmune disease or immune deficiency * Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration * Primary or secondary plasma cell leukemia * Current CNS involvement by MM * Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with adverse events (AEs) | Up to approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Serum concentration of XmAb24306 | Baseline to approximately 3 years |
| Objective response rate (ORR) | Baseline to approximately 3 years |
| Prevalence of XmAb24306 anti-drug antibodies (ADAs) | Baseline to approximately 3 years |
| Incidence of XmAb24306 ADAs | Baseline to approximately 3 years |
Countries
Australia, Denmark, Norway, Spain
Outcome results
None listed