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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-248 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-248 | Drug | subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate according to IMWG (International Myeloma Working Group) criteria | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Up to 104 weeks | |
| Complete response (CR) rate according to IMWG criteria | Up to 3.7 years | |
| MRD (minimal residual disease)-negativity rate |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.
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.
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.
Planned hematopoietic stem cell transplantation before disease progression during this study.
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.
Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:
Subjects with amyloidosis.
Clinical signs of meningeal involvement of multiple myeloma.
HIV infection, active HBV infection, hepatitis C.
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daria Liaptseva | Contact | +79816982050 | liaptseva@biocad.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBHI of the Kaliningrad region "Central City Clinical Hospital" | Not yet recruiting | Kaliningrad | Russia |
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| Up to 3.7 years |
| Duration of response | Up to 3.7 years |
| Time to progression | Up to 3.7 years |
| Time to response | Up to 3.7 years |
| Overall survival | Up to 3.7 years |
| Incidence and characteristics of adverse events | Up to 3.7 years |
| Cmax after the first administration | up to Day 6 |
| Cmin after the first administration | up to Day 6 |
| AUC0-t after the first administration | up to Day 6 |
| Ctrough | up to 6 months |
| Soluble BCMA concentration in the blood | Up to 6 months |
| Proportion of subjects with BAbs | Up to 3 years |
| Proportion of subjects with NAbs | Up to 3 years |
| SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala" | Not yet recruiting | Kazan' | Russia |
|
| FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency" | Not yet recruiting | Kirov | Russia |
|
| Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital" | Recruiting | Krasnoyarsk | Russia |
|
| Branch of the limited liability company "Hadassah Medical LTD" | Recruiting | Moscow | Russia |
|
| City Clinical Hospital №52 of the Department of Health of the City of Moscow | Recruiting | Moscow | Russia |
|
| FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation | Not yet recruiting | Moscow | Russia |
|
| JSC "Medsi Group of Companies" | Recruiting | Moscow | Russia |
|
| 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 | Not yet recruiting | Moscow | Russia |
|
| State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky" | Not yet recruiting | Moscow | Russia |
|
| Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation | Not yet recruiting | Obninsk | Russia |
|
| SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov" | Not yet recruiting | Petrozavodsk | Russia |
|
| FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation | Recruiting | Saint Petersburg | Russia |
|
| FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation | Not yet recruiting | Samara | Russia |
|
| FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia | Recruiting | Saratov | Russia |
|
| Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk" | Not yet recruiting | Smolensk | Russia |
|
| State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region | Not yet recruiting | Sochi | Russia |
|
| Public institution "Komi Republican cancer clinic" | Recruiting | Syktyvkar | Russia |
|
| FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation | Not yet recruiting | Ufa | Russia |
|
| State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1" | Not yet recruiting | Yekaterinburg | Russia |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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