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BendamustinePhase 3NCT05006469

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

A Phase 3 study testing Bendamustine in people with Bendamustine and Multiple Myeloma, run by Liao Aijun at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Observe the best dose, efficacy and adverse reactions of BAd in the treatment of relapsed and refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bendamustine, Multiple Myeloma
What is being tested?
Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Jun 2021to 31 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Liao Aijun, 18940259833, liaoaijun1001@outlook.com

    Recruiting

Other trials in China

About this study

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.

Being tested
Bendamustine
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BendamustineDrug

    Also called Liposome Adriamycin, Adriamycin, dexamethasone

    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.

Study groups in NCT05006469
Study groupRoleWhat they receive
BAd treatmentExperimentalBendamustine 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.
Receives: Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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;

    Measured: 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.

    Measured: From the start of the treatment to the end of the 6-course treatment

Secondary outcomes (1)
  1. survival

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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start1 Jun 2021
  3. Primary completion31 May 2023 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Relapsed and refractory MM received bendamustine combined with liposomal adriamycin (or adriamycin) and dexamethasone (BAd) for treatment
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05006469
Sponsor's protocol ID
2021PS168J
Status last verified
Aug 2021
First submitted
2 Aug 2021
Last updated
16 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bendamustine in people with Bendamustine and Multiple Myeloma, run by Liao Aijun at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Gao (18904152377, gaoxin121469@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR, CR, PR, MR, SD (time frame: From the start of the treatment to the end of the 6-course treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.

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