Clinical Outcome of Multiple Myeloma Patients Switching to Carfilzomib-based Regimens After Prior Bortezomib-based First-line Therapy Intolerant, a Real-world, Single-arm, Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years of age

• Diagnosed with multiple myeloma according to IMWG criteria.

• Patients who have received only first-line bortezomib-based triple therapy, including bortezomib/lenalidomide/dexamethasone (VRD), bortezomib/thalidomide/dexamethasone (VTD),bortezomib/ cyclophosphamide/dexamethasone (VCD), and bortezomib/adriamycin//dexamethasone (PAD).

• Eastern cooperative oncology group(ECOG) score 0-2

• Patients who develop toxicities associated with bortezomib therapy evaluated by the investigator, including the presence of Grade 1 with pain or Grade 2 peripheral neuropathy (PN), Grade 3 hepatic impairment, Grade 3 diarrhea, and any other Grade 3 non-hematologic adverse events and resulting in bortezomib dose reduction or discontinuation.

• Patients who agree to and sign informed consents to participate in this study.

Locations
Other Locations
China
Lingzhi Yan
RECRUITING
Suzhou
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 50
Treatments
K-based therapy
if bortezomib related intolerance happens during front line therapy of bortezomib-based triple regimen, then carfilzomib-based therapy will be used
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov