Actively Recruiting
An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma
Led by Biocad · Updated on 2025-02-04
100
Participants Needed
20
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and/or refractory multiple myeloma.
CONDITIONS
Official Title
An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older.
- Diagnosed with multiple myeloma based on IMWG criteria.
- Measurable disease present at screening.
- Received at least two prior lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 therapy.
- Documented disease progression during or after the last line of therapy according to IMWG criteria.
- Evidence of at least a partial response to one previous line of therapy as per IMWG criteria.
- ECOG performance status score between 0 and 2.
You will not qualify if you...
- Prior treatment with anti-BCMA or anti-CD3 drugs.
- Use of investigational drugs or devices within 30 days or 5 half-lives before starting study therapy, or planned use during the study except as described in the protocol.
- Autologous stem cell transplant within 12 weeks before starting study therapy or any history of allogenic stem cell transplant.
- Planned stem cell transplant before disease progression during the study.
- History of other malignancies within 5 years before screening, except certain skin cancers, carcinoma in situ of the cervix or breast, or other treated malignancies with minimal recurrence risk.
- Significant concomitant diseases increasing risk of adverse events, including severe heart conditions, uncontrolled arrhythmias, moderate to severe respiratory diseases, active autoimmune diseases (except specified exceptions), recent infections requiring systemic therapy, or other conditions increasing study risk.
- Diagnosis of amyloidosis.
- Clinical signs of meningeal involvement of multiple myeloma.
- HIV infection, active hepatitis B or C infections.
- Major surgery within 14 days before starting study therapy, incomplete recovery from surgery, or planned surgery during the study.
- Pregnancy, breastfeeding, or plans to become pregnant or father a child during the study and for 180 days after the last dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
SBHI of the Kaliningrad region "Central City Clinical Hospital"
Kaliningrad, Russia
Not Yet Recruiting
2
SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"
Kazan', Russia
Not Yet Recruiting
3
FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"
Kirov, Russia
Not Yet Recruiting
4
Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
Krasnoyarsk, Russia
Actively Recruiting
5
Branch of the limited liability company "Hadassah Medical LTD"
Moscow, Russia
Actively Recruiting
6
City Clinical Hospital №52 of the Department of Health of the City of Moscow
Moscow, Russia
Actively Recruiting
7
FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
Moscow, Russia
Not Yet Recruiting
8
JSC "Medsi Group of Companies"
Moscow, Russia
Actively Recruiting
9
SBI of health care of the city of Moscow city clinical hospital named after S. P. Botkin of the Department of health of the City of Moscow
Moscow, Russia
Not Yet Recruiting
10
State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"
Moscow, Russia
Not Yet Recruiting
11
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Obninsk, Russia
Not Yet Recruiting
12
SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
Petrozavodsk, Russia
Not Yet Recruiting
13
FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia
Actively Recruiting
14
FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
Samara, Russia
Not Yet Recruiting
15
FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
Saratov, Russia
Actively Recruiting
16
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"
Smolensk, Russia
Not Yet Recruiting
17
State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region
Sochi, Russia
Not Yet Recruiting
18
Public institution "Komi Republican cancer clinic"
Syktyvkar, Russia
Actively Recruiting
19
FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Russia
Not Yet Recruiting
20
State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"
Yekaterinburg, Russia
Not Yet Recruiting
Research Team
D
Daria Liaptseva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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