CClinicalTrials.gg
Status unknownNCT05006469Updated Aug 16, 2021

Observation of the Efficacy of BAd Regimen in the Treatment of Relapsed and Refractory Multiple Myeloma

A Phase 3 interventional study of Bendamustine in Bendamustine and Multiple Myeloma, sponsored by Liao Aijun. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-16.

Sponsored by Liao Aijun · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Observe the best dose, efficacy and adverse reactions of BAd in the treatment of relapsed and refractory multiple myeloma.

Read the detailed description

Multiple myeloma (MM) is the second most common malignant tumor of the hematological system, accounting for 10% of all hematological malignancies. With the emergence of new drugs such as proteasome inhibitors and immunomodulators, the efficacy of MM has been significantly improved, and the progression-free survival rate and overall survival rate of patients have been significantly improved. However, due to primary or secondary drug resistance, MM is still incurable , and patients will eventually be relapsed and refractory. At present, most first-line treatments contain proteasome inhibitors and immunomodulators at the same time, and patients are often resistant to these two types of drugs. CD38 monoclonal antibody is a new drug that was launched two years ago, but the price is too high, roughly 500,000 yuan a year, and most patients cannot afford it. At present, new drugs available to patients in China is still very limited, and investigator urgently need to find new treatment options among the existing drugs in China to prolong the lives of patients. Bendamustine is an alkylating agent and is currently mainly used in the treatment of lymphoma in China. But in Europe, bendamustine has been approved as a MM drug. The NCCN guidelines also include bendamustine + proteasome inhibitors or immunomodulators + hormones as the recommended treatment for MM. Because most of the patients with relapse and refractory MM have been resistant to proteasome inhibitors and immunomodulators, investigator found that the NCCN guidelines recommended schemes are not effective when used in these patients. Therefore, investigator tried to combine bendamustine with liposomes and dexamethasone (BAd) to treat relapsed and refractory MM. At present, 3 patients have been treated with this program, all of which are multi-line recurrences. Among them, 1 patient achieved complete response (CR) after 2 courses of treatment. At present, 6 courses of treatment have been completed and have been in CR state. The other 2 cases achieved partial response, and the total response rate reached 100%. The common adverse reaction in patients was hematological toxicity, but they were all tolerated. No patient stopped the drug due to adverse reactions. The price of bendamustine per course of treatment is roughly between 6000-8000 yuan, which patients can basically afford. Therefore, the program is feasible in terms of effectiveness, economy and safety. Due to the small number of patients, investigator need to further expand the number of samples to observe the optimal dose, efficacy and adverse reactions of the drug. If the program is validated and feasible, it will benefit more patients, extend their lives as much as possible, and have the opportunity to wait for other new drugs to come out.

02

Conditions studied

  • Bendamustine
  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 10 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

This is the only study on the registry with Liao Aijun as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old
  2. ≥1 line relapsed or refractory multiple myeloma
  3. 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
  4. Creatinine clearance rate>40ml/min
  5. No serious heart disease

Exclusion criteria

Exclusion Criteria:

  1. Untreated multiple myeloma patients
  2. Pregnant or lactating women
  3. 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
  4. Creatinine clearance rate ≤40ml/min
  5. Severe heart disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    BAd treatment

    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.

    Drug: Bendamustine

Interventions

  • DrugBendamustine

    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.

    Also known as: Liposome Adriamycin, Adriamycin, dexamethasone

06

What researchers measure

Primary outcomes

  1. 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;

    Time frame: From the start of the treatment to the end of the 6-course treatment

  2. The rate of adverse event

    Safety was evaluated based on hematology, nonhematology adverse events,such as thrombocytopenia,nausea,vomit.

    Time frame: From the start of the treatment to the end of the 6-course treatment

Secondary outcomes

  1. survival

    Progress free survival (PFS) is calculated to evaluate survival status.

    Time frame: 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

07

Study locations

1 of 1 sites recruiting
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning 110000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05006469
Lead sponsor
Liao Aijun
Responsible party
Liao Aijun (Director of Hematology, Shengjing Hospital) — Sponsor-investigator
First posted
Aug 16, 2021
Start date
Jun 1, 2021
Primary completion
May 31, 2023 (estimated)
Completion
May 31, 2024 (estimated)
Last update
Aug 16, 2021

Study contacts

Xin Gao
Contact
gaoxin121469@163.com
18904152377
Liao Aijun
study director · Shengjing Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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