Evaluating BCD-248 for treating relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of BCD-248 in patients suffering from relapsed or refractory multiple myeloma. Participants must have previously undergone at least two lines of therapy and show measurable disease at screening. The study will involve administering BCD-248 and monitoring the patients for responses and any adverse effects. The trial is open-label, meaning both the researchers and participants will know the treatment being administered.

Why it matters

Who can join: the full rules

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.

Where it's running

• Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
  Krasnoyarsk, Russia Recruiting
• Branch of the limited liability company "Hadassah Medical LTD"
  Moscow, Russia Recruiting
• City Clinical Hospital №52 of the Department of Health of the City of Moscow
  Moscow, Russia Recruiting
• JSC "Medsi Group of Companies"
  Moscow, Russia Recruiting
• FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation
  Saint Petersburg, Russia Recruiting
• FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia
  Saratov, Russia Recruiting

Study contacts

• Study coordinator: Daria Liaptseva
• Email: liaptseva@biocad.ru
• Phone: +79816982050

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.