A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
SCTC21C: Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
Bortezomib: Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
Lenalidomide: Pharmaceutical form: Capsules； Route of administration: Oral
Dexamethasone: Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous
Study summary
The purpose of this study is to evaluate if the addition of SCTC21C to bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma not eligible for transplant will prolong progression-free survival (PFS) and/or improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Newly diagnosed multiple myeloma (IMWG criteria) not eligible for transplant.
* Evidence of measurable disease.
* With adequate organ function and hematological parameters.
* Contraception，and during the study period and for 5 months after the last dose, all subjects must not donate reproductive cells.
Exclusion Criteria:
* Other hematologic malignancies.
* Subjects with confirmed or suspected central nervous system infiltration or meningeal involvement.
* Uncontrolled infection.
* Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.
* Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
* Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
* Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
Primary outcome measure(s)
Progression free survival (PFS) — Up to approximately 84 months after the First Participant In (FPI) Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Minimal residual disease (MRD) negativity rate for participants with CR — Up to approximately 84 months after the FPI Proportion of participants with CR for whom MRD measurement is negative
Trial sites (1)
Facility
City
Region
Status
Beijing Chaoyang Hospital affiliated to Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.