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The efficacy on the combination of bendamustine with melphalan as autologous hematopoietic stem cell transplantation preconditioning regimen in multiple myeloma.

The efficacy on the combination of bendamustine with melphalan as autologous hematopoietic stem cell transplantation preconditioning regimen in multiple myeloma.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048305
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Multiple meyloma

Interventions

Sponsors

The Department of Hematology, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years, no gender limitations; 2.Relapsed or newly diagnosed multiple myeloma who have recieved induction regimens and prepared for stem cell mobilization in autologous stem cell transplantation; 3.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; 4.Life expectancy of more than 3 months; 5.Total bilirubin <= 2.0mg/dL, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 times the upper limit of normal; 6.Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with known sensitivity to melphalan or bendamustine and the accessories ; 2.The patient also has other tumors or has a history of tumors; 3.Active hepatitis B virus infect, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive; 4Patients had uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, NYHA defined class III to IV heart failure, uncontrolled angina, congestive heart failure, clinically significant pericardial disease, or cardiac amyloidosis (NT-Pro-BNP>=1800pg/mL); 5.The patient also had severe infectious disease; 6.If the patient has a serious physical or mental illness that may interfere with participation in the clinical study, as determined by protocol or investigator; Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; 7.Patients receiving other experimental drugs; 8.Female patients who are lactating or pregnant; 9.Other patients not appropriate for the trial in the judgement of the investigator.

Design outcomes

Primary

MeasureTime frame
Complete remission and above remission rate;

Secondary

MeasureTime frame
Progression free survival rate;Overall survival rate;Minimal residual disaese negative rate;Safety;

Countries

China

Contacts

Public ContactNiu Ting

West China Hospital, Sichuan University

tingniu@sina.com+86 18980601242

Outcome results

None listed

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