Clinical trial NCT06668792: An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma
Official title: An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall response rate according to IMWG (International Myeloma Working Group) criteria
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 104 weeks
measure: Complete response (CR) rate according to IMWG criteria
timeFrame: Up to 3.7 years
measure: MRD (minimal residual disease)-negativity rate
timeFrame: Up to 3.7 years
measure: Duration of response
timeFrame: Up to 3.7 years
measure: Time to progression
timeFrame: Up to 3.7 years
measure: Time to response
timeFrame: Up to 3.7 years
measure: Overall survival
timeFrame: Up to 3.7 years
measure: Incidence and characteristics of adverse events
timeFrame: Up to 3.7 years
measure: Cmax after the first administration
timeFrame: up to Day 6
measure: Cmin after the first administration
timeFrame: up to Day 6
measure: AUC0-t after the first administration
timeFrame: up to Day 6
measure: Ctrough
timeFrame: up to 6 months
measure: Soluble BCMA concentration in the blood
timeFrame: Up to 6 months
measure: Proportion of subjects with BAbs
timeFrame: Up to 3 years
measure: Proportion of subjects with NAbs
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"
city: Kaliningrad
country: Russian Federation
facility: SBHI of the Kaliningrad region "Central City Clinical Hospital"
city: Kazan
country: Russian Federation
facility: SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"
city: Kirov
country: Russian Federation
facility: FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"
city: Krasnoyarsk
country: Russian Federation
facility: Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
city: Moscow
country: Russian Federation
facility: Branch of the limited liability company "Hadassah Medical LTD"
city: Moscow
country: Russian Federation
facility: City Clinical Hospital №52 of the Department of Health of the City of Moscow
city: Moscow
country: Russian Federation
facility: FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: JSC "Medsi Group of Companies"
city: Moscow
country: Russian Federation
facility: 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
city: Moscow
country: Russian Federation
facility: State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"
city: Obninsk
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
city: Petrozavodsk
country: Russian Federation
facility: SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
city: Saint Petersburg
country: Russian Federation
facility: FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation
city: Samara
country: Russian Federation
facility: FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
city: Saratov
country: Russian Federation
facility: FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
city: Smolensk
country: Russian Federation
facility: Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"
city: Sochi
country: Russian Federation
facility: State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region
city: Syktyvkar
country: Russian Federation
facility: Public institution "Komi Republican cancer clinic"
city: Ufa
country: Russian Federation
facility: FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Study officials:
References: