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.
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
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
Liao Aijun, 18940259833, liaoaijun1001@outlook.com
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.
- Conditions
- Bendamustine, Multiple Myeloma
- 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 group | Role | What they receive |
|---|---|---|
| BAd treatment | Experimental | 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. Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted16 Aug 2021
- Study start1 Jun 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BendamustineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Liao Aijun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liao Aijun, Shengjing Hospital
- Investigators
- Liao Aijun, Study director, Shengjing Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Efficacy of BAd Regimen in the Treatment of Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05006469
- Acronym / sponsor ID
- 2021PS168J
- Conditions
- Bendamustine, Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Liao AijunUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe the best dose, efficacy and adverse reactions of BAd in the treatment of relapsed and refractory multiple myeloma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Relapsed and refractory MM received bendamustine combined with liposomal adriamycin (or adriamycin) and dexamethasone (BAd) for treatment
| Arm | Type | Receives |
|---|---|---|
| BAd treatment | Experimental | Drug: BendamustineBendamustine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BendamustineAlso: Liposome Adriamycin, Adriamycin, dexamethasoneBendamustine 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 | BAd treatment |
Primary outcome
ORR, CR, PR, MR, SD
Time frame: From the start of the treatment to the end of the 6-course treatment
Overall response rate (ORR), complete response (CR) ,partial response (PR) ,micro response (MR) and stable disease(SD)are calculated to evaluate the efficacy;
The rate of adverse event
Time frame: From the start of the treatment to the end of the 6-course treatment
Safety was evaluated based on hematology, nonhematology adverse events,such as thrombocytopenia,nausea,vomit.
1 secondary outcome
survival
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Bendamustine
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Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
B-cell Lymphoma
Active, not recruitingPhase 3
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
Chronic Lymphocytic Leukemia
Active, not recruitingPhase 3
Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia
Active, not recruitingPhase 2
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
Hairy Cell Leukemia
Active, not recruitingPhase 3
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
Lymphoma, Mantle Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liao Aijun study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
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.