Trial Title:
An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients with Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT06668792
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BCD-248
Description:
subcutaneously
Arm group label:
BCD-248
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed informed consent form.
2. Age ≥18 years.
3. Documented diagnosis of multiple myeloma according to the IMWG criteria.
4. Measurable disease at screening.
5. Subjects who received at least 2 lines of therapy for multiple myeloma, including a
proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.
6. Documented progression according to the IMWG criteria during or after the last line
of therapy.
7. Evidence of at least a partial response according to the IMWG criteria to at least 1
previous line of therapy.
8. ECOG score 0-2.
Exclusion Criteria:
1. Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
2. Use of any investigational medicinal products or medical devices within 30 days or 5
half-lives (whichever is longer) prior to the expected start of the study therapy or
planned use of investigational medicinal products or medical devices during
participation in this study, except for the use described in this Protocol.
3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the
expected start of the study therapy or a history of allogenic stem cell
transplantation, regardless of when it was performed.
4. Planned hematopoietic stem cell transplantation before disease progression during
this study.
5. A history of other malignancies within 5 years before screening, excluding squamous
and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other
malignancies, which, in the opinion of the Investigator, have been adequately
treated and have a minimal risk of recurrence within 5 years.
6. Concomitant diseases and/or conditions that significantly increase the risk of AEs
during the study:
- Stable angina pectoris, functional class III-IV.
- Unstable angina and/or myocardial infarction within less than 6 months before
the expected start of the study therapy.
- Chronic heart failure, NYHA class III-IV;
- Clinically significant (in the Investigator's opinion) cardiac arrhythmia and
conduction disorders that do not respond to the maximum possible antiarrhythmic
therapy (therapy should be stable for 4 weeks before the expected start of the
study therapy);
- Moderate to severe asthma, grade III-IV chronic obstructive pulmonary disease,
a history of angioedema, severe respiratory failure;
- Active autoimmune diseases (subjects with type 1 diabetes mellitus and
hypothyroidism requiring only hormone replacement therapy, as well as with skin
diseases (vitiligo, alopecia, or psoriasis) that do not require systemic
therapy are eligible);
- Any infection within 14 days prior to the expected start of the study therapy,
requiring systemic etiotropic therapy or which, in the opinion of the
Investigator, may increase the risk of infectious complications;
- Any other concomitant disease or condition, which, in the Investigator's
opinion, significantly increases the risk of AEs in the study.
7. Subjects with amyloidosis.
8. Clinical signs of meningeal involvement of multiple myeloma.
9. HIV infection, active HBV infection, hepatitis C.
10. Major surgery within less than 14 days prior to the expected start of the study
therapy, incomplete recovery from surgery, or planned surgery during participation
in the study.
11. Pregnancy or breastfeeding, as well as intention to become pregnant or father a
child during the study period and within 180 days after receiving the last dose of
the IP.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"
Address:
City:
Ekaterinburg
Country:
Russian Federation
Contact:
Last name:
Tatiana Konstantinova
Facility:
Name:
SBHI of the Kaliningrad region "Central City Clinical Hospital"
Address:
City:
Kaliningrad
Country:
Russian Federation
Contact:
Last name:
Alina Chuprakova
Facility:
Name:
SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"
Address:
City:
Kazan
Country:
Russian Federation
Contact:
Last name:
Gulnara Husainova
Facility:
Name:
FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"
Address:
City:
Kirov
Country:
Russian Federation
Contact:
Last name:
Svetlana Samarina
Facility:
Name:
Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Contact:
Last name:
Elena Martynova
Facility:
Name:
Branch of the limited liability company "Hadassah Medical LTD"
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Igor Utiashev
Facility:
Name:
City Clinical Hospital №52 of the Department of Health of the City of Moscow
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Elena Misiurina
Facility:
Name:
FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Gaiane Tumian
Facility:
Name:
JSC "Medsi Group of Companies"
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Anastasia Mochalova
Facility:
Name:
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
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Vadim Doronin
Facility:
Name:
State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Tatiana Mitina
Facility:
Name:
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Address:
City:
Obninsk
Country:
Russian Federation
Contact:
Last name:
Natalia Falaleeva
Facility:
Name:
SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
Address:
City:
Petrozavodsk
Country:
Russian Federation
Contact:
Last name:
Aleksandr Miasnikov
Facility:
Name:
FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation
Address:
City:
Saint Petersburg
Country:
Russian Federation
Contact:
Last name:
Yurii Osipov
Facility:
Name:
FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
Address:
City:
Samara
Country:
Russian Federation
Contact:
Last name:
Igor Davidkin
Facility:
Name:
FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
Address:
City:
Saratov
Country:
Russian Federation
Contact:
Last name:
Tatiana Shelekhova
Facility:
Name:
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"
Address:
City:
Smolensk
Country:
Russian Federation
Contact:
Last name:
Mariia Novikova
Facility:
Name:
State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region
Address:
City:
Sochi
Country:
Russian Federation
Contact:
Last name:
Dmitrii Kirtbaia
Facility:
Name:
Public institution "Komi Republican cancer clinic"
Address:
City:
Syktyvkar
Country:
Russian Federation
Contact:
Last name:
Andrei Proidakov
Facility:
Name:
FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Address:
City:
Ufa
Country:
Russian Federation
Contact:
Last name:
Bulat Bakirov
Start date:
November 2024
Completion date:
July 2028
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06668792
