CTRI/2024/03/063867
Recruiting
Phase 3
A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of Monotherapy with BCD-264 and Darzalex® in Subjects with Relapsed and Refractory Multiple Myeloma - NI
JSC BIOCAD, Russia0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Sponsor
- JSC BIOCAD, Russia
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting all of the inclusion criteria may participate in this study:
- •1\. Signed informed consent form to participate in the study and the subject’s ability to comply with the requirements of the clinical study protocol.
- •2\. Age greater than or equal to 18 years at the time of signing of the informed consent form.
- •3\. Documented diagnosis of multiple myeloma according to IMWG criteria: (1\) Presence of greater than or equal to 10 % clonal plasma cells in bone marrow or presence of biopsy\-proven bony/extramedullary plasmacytoma
- •(2\) presence of one or more of the following symptoms
- •a) hypercalcemia: serum calcium level of more than 0\.25 mmol/L (greater than 1 mg/dL) above the upper limit of normal (ULN) or greater than 11\.0 mg/dL (greater than 2\.75 mmol/L)
- •b) renal dysfunction: serum creatinine level greater than 2 mg/dL (greater than 177 µmol/L), creatinine clearance less than 40 mL/min
- •c) anemia: hemoglobin level more than 2 g/dL (20 g/L) below the lower limit of normal (LLN) or less than 10 g/dL (less than 100 g/L)
- •d) 1 or more osteolytic bone lesions on skeletal radiography, CT or PET\-CT1
- •e) number of clonal plasmocytes in bone marrow greater than or equal to 60 %
Exclusion Criteria
- •1\. Subjects who received daratumumab or other anti\-CD38 therapy.
- •2\. Subjects treated for multiple myeloma within 2 weeks or 5 half\-lives (whichever is longer) before the date of randomization, except for a short course of glucocorticoids (equivalent to 40 mg/day of dexamethasone for up to 4 days) as rescue treatment.
- •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\. Subjects with plasma cell leukemia (greater than 2 × 109/L of circulating plasma cells in peripheral blood), POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammapathy, skin lesions) or amyloidosis.
- •7\. Subjects with 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.
Outcomes
Primary Outcomes
Not specified
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