A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma (DARVIVA)

February 28, 2024 updated by: Biocad

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

The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Chelyabinsk Regional Clinical hospital
        • Contact:
          • Alexander Korobkin
          • Phone Number: +7 (351) 749-37-10
          • Email: chelokb@mail.ru
      • Ekaterinburg, Russian Federation
        • Recruiting
        • Sverdlovsk Regional Clinical Hospital No. 1
        • Contact:
          • Tatiana Konstantinova
          • Phone Number: +7 (343) 363-03-03
          • Email: sokbinfo@mail.ru
      • Kemerovo, Russian Federation
        • Recruiting
        • Kuzbass Regional Clinical Hospital named after S.V. Belyaev
        • Contact:
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Regional Clinical Hospital
        • Contact:
      • Moscow, Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • S.P. Botkin Moscow City Clinical Hospital
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Almazov National Medical Research Centre
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • N.N. Petrov National Medicine Research Center of oncology
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • St Petersburg State I.P. Pavlov Medical University
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital
        • Contact:
          • Margarita Ulyanova
          • Phone Number: 8 (812) 670-18-88
          • Email: lokb@47lokb.ru
      • Samara, Russian Federation
        • Recruiting
        • Samara State Medical University
        • Contact:
      • Sochi, Russian Federation
        • Recruiting
        • Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
        • Contact:
      • Ufa, Russian Federation
        • Recruiting
        • Bashkir State Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent form.
  2. Age ≥ 18 years at the time of signing of the informed consent form.
  3. Documented diagnosis of multiple myeloma according to IMWG criteria

  4. Measurable disease at screening:

    1. M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
    2. light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio .
  5. At least a partial response according to IMWG criteria to at least 1 prior line of therapy.
  6. Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy
  7. ECOG score 0-2.
  8. Not pregnant and willing to use contraception.
  9. Consent to bone marrow biopsy in the study.

Exclusion Criteria:

  1. Prior treatment with daratumumab or other anti-CD38 therapy.
  2. Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
  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. Plasma cell leukemia, POEMS syndrome or amyloidosis.
  7. 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.
  11. Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCD-264

Blinded period: BCD-264 (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.

Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks
Drug: BCD-264
IV, 16 mg/kg
Other Names:
  • daratumumab
Active Comparator: Darzalex

Blinded period: Darzalex (daratumumab) will be administered intravenously once weekly for the first 8 weeks (Cycles 1 and 2), then once every two weeks for 16 weeks (Cycles 3, 4, 5 and 6). The total duration of the blinded treatment period is 6 cycles.

Open-label period: starting from Day 1 of Cycle 7, the subjects will receive open-label BCD-264 once every 4 weeks
Drug: Darzalex
IV, 16 mg/kg
Other Names:
  • daratumumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate according to IMWG (International Myeloma Working Group) criteria
Time Frame: up to 24 weeks
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: up to 3 years
up to 3 years
Overall survival
Time Frame: up to 3 years
up to 3 years
Duration of response
Time Frame: up to 3 years
up to 3 years
Stringent complete response rate according to IMWG criteria
Time Frame: up to 3 years
up to 3 years
Complete response (CR) rate according to IMWG criteria
Time Frame: up to 3 years
up to 3 years
Very good partial response (VGPR) rate according to IMWG criteria
Time Frame: up to 3 years
up to 3 years
Time to progression
Time Frame: up to 3 years
up to 3 years
Time to response
Time Frame: up to 3 years
up to 3 years

Other Outcome Measures

Outcome Measure
Time Frame
Incidence and characteristics of adverse events
Time Frame: up to 2 years
up to 2 years
Proportion of subjects with BAbs/Nabs
Time Frame: up to 2 years
up to 2 years
Time to BAb/NAb development
Time Frame: up to 2 years
up to 2 years
AUC0-168
Time Frame: up to Day 8 Cycle 1 (each cycle is 28 days)
up to Day 8 Cycle 1 (each cycle is 28 days)
AUC0-∞
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)
AUC0-336, ss
Time Frame: from Day 1 to Day 15 Cycle 6 (each cycle is 28 days)
from Day 1 to Day 15 Cycle 6 (each cycle is 28 days)
Cmax
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)
Cmax, ss
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)
Tmax
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)
T1/2
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)
Vd
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)
Ctrough, ss
Time Frame: up to Day 15 Cycle 6 (each cycle is 28 days)
up to Day 15 Cycle 6 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCD-264-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on BCD-264

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe