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A single-center, single-arm, open-label, phase II clinical study of chidamide combined with ixazomib, cyclophosphamide, and dexamethasone (ICD) in the treatment of relapsed and refractory multiple myeloma

Clinical study of histone deacetylase inhibitors reversing proteasome inhibitor resistance

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066532
Enrollment
Unknown
Registered
2022-12-08
Start date
2022-12-08
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

multiple myeloma

Interventions

Experimental group:chidamide combined with ixazomib, cyclophosphamide, and dexamethasone

Sponsors

Union Hospital Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with active multiple myeloma, relapse after initial treatment remission, failure or progression after second-line or above, including autologous stem cell transplantation; 2. Secretory multiple myeloma, with measurable indicators; 3. Aged above 18 years, no gender limit; 4. General body condition score ECOG 0-2, expected to survive more than 3 months; 5. Serum liver enzyme value =1.5x10^9/L, platelet count >=50x10^9/L, glomerular filtration rate (eGFR) >=50mL/ min; 6. Left ventricular ejection fraction was normal with no obvious cardiac or pulmonary dysfunction (<=I degree); 7. Can accept adverse reactions and efficacy observation according to the requirements of the experiment; 8. The patient must be able to understand and voluntarily sign the informed consent, which must be signed prior to any trial procedure.

Exclusion criteria

Exclusion criteria: 1. Lesions of extramedullary plasma cells; 2. Patients with grade 3 or above peripheral neuropathy at the time of enrollment; 3. Those who are being treated with other effective programmes; 4. Pregnant and lactating patients; 5. Allergic constitution, such as allergic history of two or more drugs or food; Or known allergy to the drug component; 6. Patients suffering from uncontrollable mental illness; 7. Patients with active infection; 8. There are situations that other researchers think are not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate, ORR;

Secondary

MeasureTime frame
Progression-free Survival, PFS;Duration of Response, DOR;Safety;

Countries

China

Contacts

Public ContactXu Zhenshu

Union Hospital Fujian Medical Hospital

zhenshuxu@yahoo.com+86 13365910706

Outcome results

None listed

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