Relapsed/Refractory Multiple Myeloma
Conditions
Brief summary
This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors \[PIs\], immunomodulators \[IMiDs\], and anti-cluster of differentiation 38 \[anti-CD38\] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.
Interventions
DRUGRO7851624
Participants will receive RO7851624 as per the schedule described in the protocol.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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. * Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria. * Measurable disease.
Exclusion criteria
* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment. * Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment. * Prior allogeneic SCT. * Prior solid organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentration of RO7851624 | Up to approximately 2 years |
| Objective Response Rate (ORR) | Up to approximately 2 years |
| Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate) | Up to approximately 2 years |
| Rate of Very Good Partial Response (VGPR) Rate or Better | Up to approximately 2 years |
| Progression-Free Survival (PFS) | Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| Time to First Response | Up to approximately 2 years |
| Time to Best Response | Up to approximately 2 years |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study | Baseline, up to approximately 2 years |
| Recommended Dose and Regimen of RO7851624 | Up to approximately 2 years |
Countries
Australia
Contacts
CONTACTReference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed