Trial Title:
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
NCT ID:
NCT06296121
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Daratumumab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
BCD-264
Description:
IV, 16 mg/kg
Arm group label:
BCD-264
Other name:
daratumumab
Intervention type:
Drug
Intervention name:
Darzalex
Description:
IV, 16 mg/kg
Arm group label:
Darzalex
Other name:
daratumumab
Summary:
The aim of this study is to confirm the comparability of the efficacy and safety profiles
of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in
subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and
who had disease progression on prior therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed informed consent form.
2. Age ≥ 18 years at the time of signing of the informed consent form.
3. Documented diagnosis of multiple myeloma according to IMWG criteria
4. Measurable disease at screening:
1. M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
2. light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and
abnormal κ/λ FLC ratio .
5. At least a partial response according to IMWG criteria to at least 1 prior line of
therapy.
6. Subjects with relapsed and refractory multiple myeloma who previously received
therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease
progression on prior therapy
7. ECOG score 0-2.
8. Not pregnant and willing to use contraception.
9. Consent to bone marrow biopsy in the study.
Exclusion Criteria:
1. Prior treatment with daratumumab or other anti-CD38 therapy.
2. Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date
of randomization, except for a short course of glucocorticoids
3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date
of randomization.
4. Allogeneic hematopoietic stem cell transplantation, regardless of timing.
5. Scheduled hematopoietic stem cell transplantation prior to progressive disease
during this study.
6. Plasma cell leukemia, POEMS syndrome or amyloidosis.
7. Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of
monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells
with lytic bone involvement.
8. A history of other malignancies within the last 5 years, with the exception of
squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or
other non-invasive malignancies that, in the Investigator's opinion are considered
to have been adequately treated and have a minimal risk of recurrence for 5 years.
9. Plasmapheresis within 28 days prior to randomization.
10. Clinical signs of meningeal involvement of multiple myeloma.
11. Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and
within 3 months after the last dose of daratumumab; for male subjects, planning to
conceive a child throughout the study and within 3 months after the last dose of
daratumumab.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chelyabinsk Regional Clinical Hospital
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Alexander Korobkin
Phone:
+7 (351) 749-37-10
Email:
chelokb@mail.ru
Facility:
Name:
Sverdlovsk Regional Clinical Hospital No. 1
Address:
City:
Ekaterinburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Tatiana Konstantinova
Phone:
+7 (343) 363-03-03
Email:
sokbinfo@mail.ru
Facility:
Name:
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
Address:
City:
Kemerovo
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Marina Kosinova
Phone:
8(384-2)39-65-33
Email:
o5-guz-kokb@kuzdrav.ru
Facility:
Name:
Regional Clinical Hospital
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Elena Martynova
Phone:
+7 (391) 202-68-50
Email:
kkb@medgorod.ru
Facility:
Name:
Moscow City Clinical Hospital 52
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Elena Misyurina
Phone:
+7 (495) 870-36-04
Email:
gkb52international@gmail.com
Facility:
Name:
S.P. Botkin Moscow City Clinical Hospital
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vadim Doronin
Phone:
+7 495 945 9972
Email:
botkinhospital@zdrav.mos.ru
Facility:
Name:
Almazov National Medical Research Centre
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Yuri Osipov
Phone:
+7 (812) 660-37-06
Email:
fmrc@almazovcentre.ru
Facility:
Name:
N.N. Petrov National Medicine Research Center of oncology
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ilya Zyuzgin
Phone:
+7(812)43-99-555
Email:
oncl@rion.spb.ru
Facility:
Name:
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sergei Voloshin
Phone:
+78123097982
Email:
bloodscience@mail.ru
Facility:
Name:
St Petersburg State I.P. Pavlov Medical University
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ivan Moiseev
Phone:
(812) 338 67 48
Email:
opmu@spb-gmu.ru
Facility:
Name:
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Margarita Ulyanova
Phone:
8 (812) 670-18-88
Email:
lokb@47lokb.ru
Facility:
Name:
Samara State Medical University
Address:
City:
Samara
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Igor Davydkin
Phone:
8 (846) 374-91-00
Email:
clinica@samsmu.ru
Facility:
Name:
Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
Address:
City:
Sochi
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Dmitrii Kirtbaya
Phone:
(862) 261-43-89
Email:
onko13@sochi.com
Facility:
Name:
Bashkir State Medical University
Address:
City:
Ufa
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Bulat Bakirov
Phone:
8 (347) 272-41-73
Email:
rectorat@bashgmu.ru
Start date:
December 21, 2023
Completion date:
July 2026
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/NCT06296121
