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Effect of bendamustine combined with melphalan on preconditioning before autologous hematopoietic stem cell transplantation for multiple myeloma

Effect of bendamustine combined with melphalan on preconditioning before autologous hematopoietic stem cell transplantation for multiple myeloma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047782
Enrollment
Unknown
Registered
2021-06-26
Start date
2021-07-30
Completion date
Unknown
Last updated
2022-02-28

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:No

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18to 75 years old, male or female; 2. Multiple myeloma patients receiving induction therapy and preparing for mobilization of stem cells for autologous transplantation, including patients who are initially treated and relapse-refractory; 3. ECOG10.0 g/L; (2) Urinary M protein >=200mg/24h; (3) Abnormal ? /? FLC ratio and involvement of free light chain (FLC) >=100 mg/L when serum free light chain was determined or no lesions were detected in serum or urine. 5, TBil <=2.0mg/dL, AST, ALT<=3.0xULN; 6. Informed Consent has been signed. Informed consent was signed by the patient himself or his immediate family. Considering the patient's condition, if the signature of the patient is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family member should sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are known to be allergic to bendamustine, melphalan or their excipients; 2. The patient has other tumors at the same time or a previous history of tumors; 3. Known patients with active hepatitis B virus or hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serological positive; 4. Patients had uncontrolled or severe cardiovascular disease, including myocardial infarction within the first 6 months of enrolement, New York College of Cardiology (NYHA) defined iii-lead heart failure, uncontrolled angina pectoris, congestive heart failure, clinically significant pericardial disease, or cardiac amyloidosis (NT-pro-BNP >=1800pg/mL); 5. The patient is accompanied by severe infectious diseases; 6. According to the protocol or the investigator's judgment, the patient suffers from a serious physical or mental illness that may interfere with the participation in the clinical study; Substance abuse, medical, psychological, or social conditions that may interfere with subjects' participation in the study or evaluation of study results; 7. Patients receiving other experimental drug therapy; 8. Pregnant or lactating women; 9. Not suitable for participants considered by the researcher.

Design outcomes

Primary

MeasureTime frame
complete remission rate;

Secondary

MeasureTime frame
Progression Free Survival;overall survival;minimal residual disease negative rate;security;

Countries

China

Contacts

Public ContactLiu Zhigang

West China Hospital, Sichuan University

hxdoctorliu@126.com+86 18980606798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026