Efficacy and safety of chidamide, bortezomib and dexamethasone combination in transplant-ineligible patients with relapsed/refractory multiple myeloma: a phase 2, single center, single arm study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-16010301

Enrollment

Unknown

Registered

2016-12-31

Start date

2017-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

Case series:bortezomib, chidamide and dexamethasone combination protocol

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Men and women, aged above 18 years; 2. Subjects have diagnosed multiple myeloma, and previously treated with standard regimens; chidamide naive; 3. ECOG performance status (PS) score 0-2; 4. AST and ALT <=3 times the institutional ULN; Total bilirubin <=2.0 times the institutional ULN Serum creatinine<2.0 times the institutional ULN; 5. Women or men must take effective contraceptive measures, in women Serum or urine pregnancy tests must be negative in the screening and study periods; 6. Patients understand the disease and voluntarily received the study regimen and follow-up.

Exclusion criteria

Exclusion criteria: 1. Frail to receive chemotherapy; 2. Uncontrolled DM; 3. Subjects suffered from AIDS or activitive hepatitis B or C virus; 4.Severe peripheral neuropathy or bortezomib intolerant patients; 5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.

Design outcomes

Secondary

Measure	Time frame
Progression free survival;Overall survival;	—

Primary

Measure	Time frame
Complete response rate;Overall response rate;	—

Contacts

Public ContactZhongjun XIA

xiazhj@sysucc.org.cn+86 020-87342438

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026