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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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