Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma

This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.The enrollment period for this study is expected to be approximately 12 months. The study will end when all patients have completed 12 cycles treatment/

Trial Details

NCT ID
NCT05422027
Phase
PHASE1 / PHASE2
Sponsor
Xia Zhongjun
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Selinexor
  • Bortezomib
  • Lenalidomide
  • Dexamethasone
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
  • Willing and able to written informed consent (ICF) .
  • Age ≥ 18 years.
  • Newly diagnosed multiple myeloma as defined by IMWG(Rajkumar, Dimopoulos et al. 2014) , measurable disease as defined IMWG 2016 criteria(Table 5) (…

For full eligibility, visit ClinicalTrials.gov.

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