BCD-248 plus daratumumab in 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 Phase 3 trial compares two regimens in adults with measurable, relapsed or refractory multiple myeloma: BCD-248 with daratumumab versus daratumumab with pomalidomide and dexamethasone. Eligible participants have had 1 to 3 prior anti-myeloma therapies including lenalidomide and a proteasome inhibitor and must have progressed on or after last therapy. The study aims to determine if the BCD-248 combination improves efficacy and maintains safety compared with the established control. Key assessments include disease progression, response, and treatment-related adverse events. The trial is conducted at multiple sites in the region with Biocad as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent form.
* Age ≥18 years.
* Documented diagnosis of multiple myeloma according to the IMWG criteria.
* Measurable disease at screening.
* At least 1, but not more than 3 prior lines of antimyeloma therapy, including lenalidomide and a proteasome inhibitor.
* Documented progression according to the IMWG criteria during or after the last line of therapy.
* ECOG score 0-2.
* Resolution of symptoms of toxicity on the prior line of therapy.

Exclusion Criteria:

* Prior therapy with anti-BCMA or anti-CD3 drugs, pomalidomide.
* Refractory to anti-CD38 monoclonal antibodies according to the IMWG criteria.
* Use of any investigational products or medical devices within 28 days prior to randomization or planned use of investigational products or medical devices during participation in this study.
* Hematopoietic stem cell transplantation - prior to randomization or planned during the study
* Plasmapheresis within 14 days prior to randomization.
* Administration of a live attenuated vaccine within 28 days prior to randomization.
* A history of myelodysplastic syndrome or other malignancies other than multiple myeloma within 5 years prior to screening.
* Life-threatening acute complications of the underlying disease.
* Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:

  1. Stable angina pectoris, functional class III-IV.
  2. Unstable angina pectoris and/or myocardial infarction within 6 months prior to randomization.
  3. Congestive heart failure, NYHA class III-IV.
  4. Clinically significant (according to the Investigator) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy must be stable for 4 weeks before the planned start of the study therapy).
  5. Moderate to severe asthma, uncontrolled asthma, asthma with forced expiratory volume in 1 second \<50% of predicted normal.
  6. Chronic obstructive pulmonary disease with forced expiratory volume in 1 second \<50% of predicted normal.
  7. A history of angioneurotic edema, severe respiratory failure.
  8. Active autoimmune diseases. Patients with type 1 diabetes mellitus and hypothyroidism, requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, psoriasis, etc.), which do not require systemic therapy, are allowed to participate.
  9. Thromboembolic (deep vein thrombosis, pulmonary embolism) or cerebrovascular (stroke, transient ischemic attack) events within 6 months prior to randomization.
  10. Any infection within 14 days prior to randomization that requires systemic etiological therapy or may, in the Investigator's opinion, increase the risk of infectious complications.
  11. Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.
* Subjects with amyloidosis, POEMS syndrome, plasma cell leukemia
* CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
* HIV infection, active HBV infection, hepatitis C.
* Hypersensitivity, allergy, or intolerance to monoclonal antibodies or any component of BCD-248, daratumumab, pomalidomide, or dexamethasone.
* 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.
* 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

• SI "Republican Scientific and Practical Center for Radiation Medicine and Human Ecology"
  Homyel, Belarus Recruiting
• SBHI "Chelyabinsk regional clinical hospital"
  Chelyabinsk, Russia Recruiting
• SBHI "Regional oncological dispensary"
  Irkutsk, Russia Recruiting
• SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
  Kazan', Russia Recruiting
• Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"
  Krasnoyarsk, Russia Recruiting
• Branch Office of Hadassah Medical Ltd.
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Evgeniia Mikhailova
• Email: mikhailova@biocad.ru
• Phone: +79110812368

Similar studies

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

• Daratumumab-hyaluronidase added to your myeloma treatment to see if it helps kidney function

  This trial tests whether adding daratumumab-hyaluronidase to the standard bortezomib and dexamethasone therapy improves kidney function in adults newly diagnosed with multiple myeloma and kidney failure.

  Recruiting Phase 2 Eastern Cooperative Oncology Group · Anchorage, Alaska · NCT07085728

• Fewer-doses daratumumab added to VRd for newly diagnosed multiple myeloma

  This study tests whether a less-frequent daratumumab dosing plan added to VRd can help patients with newly diagnosed multiple myeloma achieve more MRD negativity.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra and 1 other locations · NCT07891923

• Immune Fitness in Older Adults with Relapsed or Refractory Multiple Myeloma

  This study checks whether immune health before treatment can predict how well older adults with relapsed or refractory multiple myeloma respond to CAR-T or bispecific antibody therapies.

  Recruiting Jules Bordet Institute · Anderlecht, Brussels Capital and 2 other locations · NCT07674498

• Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis

  This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.

  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai · NCT07638683

• Infectious complications in blood cancer patients treated with bispecific antibodies

  This study tests how often infections occur in adults with blood cancers who are being treated with bispecific antibodies.

  Recruiting at 2 sites Infanta Leonor University Hospital · Madrid, Madrid and 1 other locations · NCT07609576

• Mapping individual multiple myeloma biology to understand relapse and treatment resistance

  This project will test whether combining clinical records with whole-genome and RNA sequencing plus blood tumor markers in people with multiple myeloma can reveal features that explain relapse and treatment resistance.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bo · NCT07582354

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.