Observation of the Efficacy of BAd Regimen in the Treatment of Relapsed and Refractory Multiple Myeloma
1 other identifier
interventional
10
1 country
1
Brief Summary
Observe the best dose, efficacy and adverse reactions of BAd in the treatment of relapsed and refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2021
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedAugust 16, 2021
August 1, 2021
2 years
August 2, 2021
August 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
ORR, CR, PR, MR, SD
Overall response rate (ORR), complete response (CR) ,partial response (PR) ,micro response (MR) and stable disease（SD）are calculated to evaluate the efficacy;
From the start of the treatment to the end of the 6-course treatment
The rate of adverse event
Safety was evaluated based on hematology, nonhematology adverse events,such as thrombocytopenia,nausea,vomit.
From the start of the treatment to the end of the 6-course treatment
Secondary Outcomes (1)
survival
From the start of the treatment until the disease progresses.If the patient has no disease progression, the follow-up time will end 1 year after the treatment
Study Arms (1)
BAd treatment
EXPERIMENTALBendamustine 70-90mg/m2, d1, d2 Liposome Adriamycin 15-20mg/m2, d1 or Adriamycin 10mg d1-d4 Dexamethasone 40mg qw po. (20mg, \>70 years old) There is a course of treatment every 28 days, and a total of 6 courses are completed.
Interventions
Bendamustine 70-90mg/m2, d1, d2 Liposome Adriamycin 15-20mg/m2, d1 or Adriamycin 10mg d1-d4 Dexamethasone 40mg qw po. (20mg, \>70 years old) There is a course of treatment every 28 days, and a total of 6 courses are completed.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old
- ≥1 line relapsed or refractory multiple myeloma
- Alanine aminotransferase is less than 2.5 times the upper limit of normal, and total bilirubin is less than 1.5 times the upper limit of normal
- Creatinine clearance rate\>40ml/min
- No serious heart disease
You may not qualify if:
- Untreated multiple myeloma patients
- Pregnant or lactating women
- Alanine aminotransferase is more than 2.5 times the upper limit of normal, and total bilirubin is more than 1.5 times the upper limit of normal
- Creatinine clearance rate ≤40ml/min
- Severe heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liao Aijunlead
Study Sites (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liao Aijun
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Hematology
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 16, 2021
Study Start
June 1, 2021
Primary Completion
May 31, 2023
Study Completion
May 31, 2024
Last Updated
August 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share