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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046675
Enrollment
Unknown
Registered
2021-05-26
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-04

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 of the Affiliated Hospital of Southwest Medical 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 refractory to prior lenalidomide or/and bortezomib (either in combination or sequential)therapy (i.e. history of progression on therapy or within 60 days after completion); 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 pomalidomide or bendamustine or dexamethasone and the accessories ; 2.Active treatment or intervention for other malignancy or need active treatment within 4 weeks of starting study treatment. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection; 3.Active hepatitis B virus infect, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive; 4.Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure(NT-Pro-BNP>=1800pg/mL), unstable angina, or myocardial infarction within the past 6 months; 5.Infection requiring systemic antibiotic therapy or other serious infection; 6.Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Psychiatric illness/social situation that would limit compliance with study requirements; 7.Under other clinical trial procedures; 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;MRD negative rate;Safety;

Countries

China

Contacts

Public ContactXing Hongyun

The Affiliated Hospital of Southwest Medical University

xinghy52003@foxmail.com+86 18283035160

Outcome results

None listed

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