BCD-248-2/FLAMMINGO "An open-label clinical study to evaluate the efficacy and safety of BCD-248 in subjects with relapsed/refractory multiple myeloma".
During the clinical study BCD-248-2/FLAMMINGO, the efficacy and safety of the investigational drug BCD-248 administered for relapsed and/or refractory multiple myeloma will be evaluated in participants who:
Are aged 18 years and older.
Have a documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria1.
Meet the following criteria at screening2:
M-gradient ≥ 1.0 g/dL (10 g/L) in serum or ≥ 200 mg/day in daily urine; or
Received at least two lines of therapy for multiple myeloma (≥ 1 completed cycle for each therapy line) that included a proteasome inhibitor, immunomodulatory drug, CD3844-targeted therapy, provided they had documented disease progression during or after the last line of therapy.
Have evidence of at least a partial response according to IMWG criteria (assessed by the Clinical Investigator) to at least one line of the previous therapy.
Have an ECOG performance score5 of 0-2.
Agree to use effective contraception methods during the clinical study and within three months after the last dose of the investigational drug, and are willing to abstain from egg or sperm donation during this period.
The clinical study protocol includes bone marrow aspiration and biopsy as part of the study.
This clinical study has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical study); the full list will be provided to a potential participant by the Clinical Investigator. Among other factors, the non-inclusion criteria include the following:
Previous anti-BCMA therapy6 or anti-CD3 therapy7.
Previous therapy for multiple myeloma for 30 days or five half-lives (whichever is longer) prior to the anticipated time of the first dose of investigational drug BCD-2488.
Other antitumor therapy, including chemotherapy, targeted therapy, immunotherapy, radiation therapy within three weeks or five half-lives (whichever is longer) prior to the anticipated first dose of BCD-248 , except for a short-term treatment of glucocorticoids (equivalent to approximately 40 mg/day of dexamethasone for a maximum of 4 days) for urgent indications.
Autologous hematopoietic stem cell transplantation within 12 weeks prior to the anticipated time of the first dose of the investigational drug or allogeneic hematopoietic stem cell transplantation regardless of the period of prescription.
Planned hematopoietic stem cell transplantation prior to disease progression while participating in a clinical study.
History of other malignancies within the past five years prior to screening, excluding squamous cell and basal cell skin cancer, cervical carcinoma in situ, breast cancer, or other non-invasive malignancies that, in the opinion of the Clinical Investigator, are considered adequately treated and have a minimal risk of recurrence within the five years prior to screening.
Comorbidities and/or concomitant conditions that significantly increase the risk of adverse events during the study:
Stable angina, functional class III-IV.
Unstable angina and/or myocardial infarction less than 6 months prior to the anticipated treatment during the study.
NYHA stage III-IV CHF9.
Clinically significant cardiac rhythm and conduction abnormalities that, at the discretion of the Clinical Investigator, are not amenable to maximum possible antiarrhythmic therapy (therapy must show stability for four weeks prior to the anticipated date of the study therapy).
Moderate and severe bronchial asthma, stage III-IV chronic obstructive pulmonary disease, history of angioneurotic oedema, severe respiratory failure.
Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and with skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy are eligible).
Any infection within 14 days prior to the anticipated date of the study therapy that requires systemic etiotropic therapy or that may, in the opinion of the Clinical Investigator, increase the risk of infectious complications.
Any other comorbidity or concomitant condition that, according to the Clinical Investigator, significantly increases the risk of adverse events during the clinical study.
Amyloidosis.
Clinical signs of multiple myeloma with brain involvement.
HIV infection, active viral hepatitis B, hepatitis C.
Pregnancy or breastfeeding, or planning pregnancy or parenthood during the clinical study and within three months after the last dose of the investigational drug.
Major surgical procedures performed less than 14 days prior to the anticipated date of the study therapy, incomplete recovery from a previous surgical procedure, or planned surgical procedures while participating in a clinical study.
The clinical study BCD-248-2/FLAMMINGO is conducted in study centers in various cities of the Russian Federation, including Ufa, Samara, Moscow, Sochi, Yekaterinburg, Krasnoyarsk, Petrozavodsk, Smolensk, St. Petersburg, Syktyvkar, Kirov, Kazan, Kaliningrad, and Saratov.
To query about participating in a clinical study, including contact details of study centers, please use a special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study, as well as about other drug products used in the study. The potential participant should read the complete study information and consult with the Clinical Investigator and (or) Treating Physician.
Clinical Study Authorization No. 470 dated October 14, 2024 of the Ministry of Health of the Russian Federation and the list of approved study centers are published in the State Register of Medicines.
IMWG — International Myeloma Working Group.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical study according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.
FLC — free light chains.
CD38 (cluster of differentiation 38) — a glycoprotein that is encoded by the CD38 gene located on chromosome 4p15.
ECOG scale is a scale that determines the subject's functional status in terms of his/her ability to self-care, daily functioning, and physical activities.
BCMA is a B-cell maturation antigen which is a cell membrane protein involved in the differentiation and maturation of B-lymphocytes in plasma cells.
CD3 (cluster of differentiation 3) — a protein complex on the surface of T lymphocytes.
Investigational drug is a drug product that is being tested in the study or is used as a comparator, including placebo, including an authorized drug product (if its route of administration differs from the approved one, as well as if it is used for a new indication or to obtain additional information for an approved indication).
NYHA is a New York Heart Association classification of chronic heart failure.