A Study to Evaluate RO7851624 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RO7851624.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma
Overview
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
- Drug RO7851624
Participants will receive RO7851624 as per the schedule described in the protocol.
Primary outcome measures
- Percentage of Participants With Adverse Events (AEs) [Time frame: Up to approximately 2 years]
Secondary outcome measures (10)
- Serum Concentration of RO7851624 [Time frame: Up to approximately 2 years]
- Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
- Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate) [Time frame: Up to approximately 2 years]
- Rate of Very Good Partial Response (VGPR) Rate or Better [Time frame: Up to approximately 2 years]
- Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
- Duration of Response (DOR) [Time frame: Up to approximately 2 years]
- Time to First Response [Time frame: Up to approximately 2 years]
- Time to Best Response [Time frame: Up to approximately 2 years]
- Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study [Time frame: Baseline, up to approximately 2 years]
- Recommended Dose and Regimen of RO7851624 [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Peter MacCallum Cancer Center — Parkville
Identifiers
NCT: NCT07558915 · GO46140