Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05006469 |
| Other study ID # |
2021PS168J |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
August 2021 |
| Source |
Shengjing Hospital |
| Contact |
Xin Gao |
| Phone |
18904152377 |
| Email |
gaoxin121469[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Observe the best dose, efficacy and adverse reactions of BAd in the treatment of relapsed and
refractory multiple myeloma.
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.
