An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma

NCT06668792 | Recruiting Phase 2 DMC

• 1 other identifier: BCD-248-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate according to IMWG (International Myeloma Working Group) criteria

  Up to 24 weeks

Secondary Outcomes (15)

• 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

  Up to 3.7 years

• Duration of response

  Up to 3.7 years

• Time to progression

  Up to 3.7 years

Study Arms (1)

BCD-248

EXPERIMENTAL

Drug: BCD-248

Interventions

BCD-248 DRUG

subcutaneously

BCD-248

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Age ≥18 years.
• Documented diagnosis of multiple myeloma according to the IMWG criteria.
• Measurable disease at screening.
• Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.
• Documented progression according to the IMWG criteria during or after the last line of therapy.
• Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.
• ECOG score 0-2.

You may not qualify if:

• 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:
• 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.
• Subjects with amyloidosis.

Sponsors & Collaborators

• Biocad: lead

Study Sites (20)

SBHI of the Kaliningrad region "Central City Clinical Hospital"

Kaliningrad, Russia

NOT YET RECRUITING

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

FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"

Kirov, Russia

NOT YET RECRUITING

Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"

Krasnoyarsk, Russia

RECRUITING

Branch of the limited liability company "Hadassah Medical LTD"

Moscow, Russia

RECRUITING

City Clinical Hospital №52 of the Department of Health of the City of Moscow

Moscow, Russia

RECRUITING

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

JSC "Medsi Group of Companies"

Moscow, Russia

RECRUITING

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

State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"

Moscow, Russia

NOT YET RECRUITING

Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

Obninsk, Russia

NOT YET RECRUITING

SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"

Petrozavodsk, Russia

NOT YET RECRUITING

FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

RECRUITING

FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation

Samara, Russia

NOT YET RECRUITING

FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia

Saratov, Russia

RECRUITING

Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"

Smolensk, Russia

NOT YET RECRUITING

State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region

Sochi, Russia

NOT YET RECRUITING

Public institution "Komi Republican cancer clinic"

Syktyvkar, Russia

RECRUITING

FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation

Ufa, Russia

NOT YET RECRUITING

State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"

Yekaterinburg, Russia

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Daria Liaptseva

CONTACT

+79816982050; liaptseva@biocad.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: December 26, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (20)