RUENCN

BCD-264-2/DARVIVA

More about the molecule

Multiple Myeloma

A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-264 and Darzalex® as Monotherapy in Subjects with Relapsed and Refractory Multiple Myeloma

The purpose of this clinical study is to confirm the comparable efficacy and safety profile of the test drug BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects who have previously received therapy with proteasome inhibitors and immunomodulatory drugs and who have experienced disease progression during prior therapy and who:

  • Have reached the age of 18 years;
  • Have a documented diagnosis of multiple myeloma according to IMWG diagnostic criteria1;
  • Meet the screening criteria2:
    • Serum M-protein level ≥1.0 g/dL (10 g/L) or 24-hour urine M-protein level ≥200 mg; or
    • Light chain myeloma: serum level of involved FLCs ≥10 mg/dL (100 mg/L) and abnormal FLC κ/λ ratio3;
    • Have a diagnosis of relapsed and refractory multiple myeloma, have previously received therapy with proteasome inhibitors and immunomodulators, and have experienced disease progression during prior therapy;
    • Have an ECOG score4 of 0–2;
    • Agree to use reliable contraception during and for 3 months after their participation in the clinical study, and to refuse to donate eggs or sperm during this period.

    The clinical study protocol requires an aspiration biopsy and/or trephine biopsy of the bone marrow as part of the study.

    This study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, the exclusion criteria are:

    • Prior therapy with daratumumab or other anti-CD38 therapy.5
    • Prior therapy for multiple myeloma for 2 weeks or 5 elimination half-lives (whichever is longer) prior to the first dose of the investigational product, excluding a short course of glucocorticoids for emergency indications.
    • Autologous hematopoietic stem cell transplantation within 12 weeks prior to the first dose of the investigational product.
    • Allogeneic hematopoietic stem cell transplantation, regardless of when it was performed.
    • Planned hematopoietic stem cell transplantation before disease progression during this study.
    • Plasma cell leukemia (>2x109/L circulating plasma cells in peripheral blood), POEMS syndrome6 or amyloidosis.
    • Waldenstrom disease or other concomitant diseases associated with overproduction of monoclonal IgM (M protein) in the absence of clonal proliferation of plasma cells with lytic bone lesions.
    • A history of other malignancies within the past 5 years, excluding squamous and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other non-invasive malignancies, which, in the opinion of the Investigator, have been adequately treated and have a minimal risk of recurrence within 5 years.
    • Plasmapheresis within 28 days before randomization7.
    • Clinical signs of multiple myeloma in the brain.
    • Concomitant diseases: COPD8 (forced expiratory volume in 1 second <50% of normal value), persistent moderate to severe asthma, or a history of asthma within the previous 2 years, or any uncontrolled asthma.
    • HIV infection, hepatitis B, hepatitis C.
    • Hypersensitivity, allergy, or intolerance to monoclonal antibodies or any component of the test/reference drug.
    • Pregnancy or breastfeeding, planned pregnancy or fatherhood throughout the study and for 3 months after the last dose of the investigational product.

    Clinical study BCD-264-2/DARVIVA is underway in the Russian Federation at study centers of St. Petersburg, Moscow, Ufa, Samara, Sochi, Yekaterinburg, Chelyabinsk, Kemerovo, Obninsk, Krasnoyarsk, Novosibirsk, Syktyvkar, and Kirov.

    You can ask questions about participation in the clinical study and clarify contact information of study centers through the “Any questions?” form.


    The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.

    Clinical Study Authorization No. 599 of the Ministry of Health of the Russian Federation dated October 19, 2023, and the list of approved study centers have been published in the State Register of Medicines.

    1. IMWG, diagnostic criteria for multiple myeloma approved by the International Myeloma Working Group.
    2. Screening is a pre-specified period for assessing the possibility of participation of a subject in a clinical study according to the eligibility criteria, based on the results of diagnostic procedures and specialist consultations.
    3. FLC, Free Light Chains of immunoglobulins.
    4. ECOG scale measures the performance of the patient in terms of his/her ability to take care of himself/herself, daily activities, and physical activity.
    5. Anti-CD38, cluster of differentiation 38.
    6. POEMS syndrome, Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy, and Skin Lesions.
    7. Randomization is the procedure for distributing patients into groups for the use of investigational products.
    8. COPD, Chronic Obstructive Pulmonary Disease.