Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma. Phase IIa. To further evaluate the safety and tolerability of Purinostat Mesylate for Injection at the RP2D combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM). Secondary Objectives Phase Ib 1. To evaluate the safety and tolerability o

Trial Details

NCT ID
NCT06484829
Phase
PHASE1 / PHASE2
Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Purinostat Mesylate 4 mg/m2
  • Purinostat Mesylate 6 mg/m2
  • Purinostat Mesylate 8.4 mg/m2
Locations (sample)
  • Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility Criteria

  • Diagnosed with multiple myeloma (MM) by reference to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple …
  • Those who have received at least one line of prior systemic antimyeloma therapy (which must include lenalidomide and proteasome inhibitors; see App…
  • Age 18-75 years, male or female, if of childbearing potential subjects should be on effective contraception and must agree to comply with all contr…
  • 1\) Females of childbearing potential must agree to and comply with the contraceptive measures specified in the protocol: beginning 4 weeks prior t…

For full eligibility, visit ClinicalTrials.gov.

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