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Multi-center, open-label phase II trial of CPT in MM: stage I

Multi-center, open-label phase II trial of CPT in MM: stage I

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002065
Enrollment
Unknown
Registered
2012-03-31
Start date
2007-09-01
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

Relapsed or Refractory Multiple Myeloma

Interventions

Sponsors

CCMU Beijing Chaoyang Hostipital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnosis criteria; 2. MM that is refractory to standard of care or relapsed from response; 3. Age >=18 years; 4. Karnofsky Performance Status Score >=60; 5. Life expectancy >=3 months; 6. No prior chemotherapy, radiotherapy, target therapy, angiogenesis inhibitor or interferon within the last 2 weeks; 7. No significant major organ disorder and laboratory tests meeting the following: Hematology: WBC>=2.0*10^9/L, neutrophil>=1.5*10^9/L, Platelet count>=30*10^9/L, hemoglobin>=60g/L; Liver function: serum total bilirubin, ALT and AST10ml/min; 8. Signed Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Prior history of hypersensitivity to biological products including protein or allergic constitution; 3.Prior history of viral hepatitis or other liver diseases; 4.Present orA history of mental disorder; 5. Serious or uncontrolled disorder of major organs (cardiovascular, respiratory, gastrointestinal, neurologic, etc.) within 6 months prior to enrollment, including cardiac infarction, Grade III-IV heart failure, angina, heart disease with significant clinical manifestations, left ventricular ejection fraction <0.5, serious conduction dysfunction; or hypotension (sitting SBP<=90mmHg or sitting DBP<=60mmHg.); 6. Other types of tumor; 7. Other conditions that in the investigator’s opinion preclude participation in the study.

Design outcomes

Primary

MeasureTime frame
ORR;AE;

Countries

China

Contacts

Public ContactWenming Chen

Beijing Chaoyang Hostipital

xybxx@ccmu.edu.cn+86 010 85231571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026