Multiple MyelomaPhase 3DARVIVANCT06296121
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 3 study testing BCD-264 and Darzalex in people with Multiple Myeloma, run by Biocad at 14 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCD-264 and Darzalex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 14 sitesRussia
- Study dates
- 21 Dec 2023to Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Age ≥ 18 years at the time of signing of the informed consent form.
- Documented diagnosis of multiple myeloma according to IMWG criteria
- Measurable disease at screening:
- M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
- light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio .
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- At least a partial response according to IMWG criteria to at least 1 prior line of therapy.
- 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
- ECOG score 0-2.
- Not pregnant and willing to use contraception.
- Consent to bone marrow biopsy in the study.
Who cannot join
- Prior treatment with daratumumab or other anti-CD38 therapy.
- Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
- Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
- Allogeneic hematopoietic stem cell transplantation, regardless of timing.
- Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
- Plasma cell leukemia, POEMS syndrome or amyloidosis.
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- 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.
- 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.
- Plasmapheresis within 28 days prior to randomization.
- Clinical signs of meningeal involvement of multiple myeloma.
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites, 14 recruiting
- Recruiting
Chelyabinsk Regional Clinical Hospital
Chelyabinsk
Alexander Korobkin, +7 (351) 749-37-10, chelokb@mail.ru
- Recruiting
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
Kemerovo
Marina Kosinova, 8(384-2)39-65-33, o5-guz-kokb@kuzdrav.ru
- Recruiting
Regional Clinical Hospital
Krasnoyarsk
Elena Martynova, +7 (391) 202-68-50, kkb@medgorod.ru
- Recruiting
Moscow City Clinical Hospital 52
Moscow
Elena Misyurina, +7 (495) 870-36-04, gkb52international@gmail.com
- Recruiting
S.P. Botkin Moscow City Clinical Hospital
Moscow
Vadim Doronin, +7 495 945 9972, botkinhospital@zdrav.mos.ru
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg
Yuri Osipov, +7 (812) 660-37-06, fmrc@almazovcentre.ru
- Recruiting
N.N. Petrov National Medicine Research Center of oncology
Saint Petersburg
Ilya Zyuzgin, +7(812)43-99-555, oncl@rion.spb.ru
- Recruiting
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
Saint Petersburg
Sergei Voloshin, +78123097982, bloodscience@mail.ru
- Recruiting
St Petersburg State I.P. Pavlov Medical University
Saint Petersburg
Ivan Moiseev, (812) 338 67 48, opmu@spb-gmu.ru
- Recruiting
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg
Margarita Ulyanova, 8 (812) 670-18-88, lokb@47lokb.ru
- Recruiting
Samara State Medical University
Samara
Igor Davydkin, 8 (846) 374-91-00, clinica@samsmu.ru
- Recruiting
Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
Sochi
Dmitrii Kirtbaya, (862) 261-43-89, onko13@sochi.com
- Recruiting
Bashkir State Medical University
Ufa
Bulat Bakirov, 8 (347) 272-41-73, rectorat@bashgmu.ru
- Recruiting
Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg
Tatiana Konstantinova, +7 (343) 363-03-03, sokbinfo@mail.ru
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- BCD-264, Darzalex
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-264Drug
Also called daratumumab
IV, 16 mg/kg
DarzalexDrug
Also called daratumumab
IV, 16 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| BCD-264 | Experimental | 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 Receives: Drug: BCD-264 |
| Darzalex | Active comparator | 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 Receives: Drug: Darzalex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate according to IMWG (International Myeloma Working Group) criteria
Measured: up to 24 weeks
Secondary outcomes (8)
Stringent complete response rate according to IMWG criteria
Measured: up to 3 years
Complete response (CR) rate according to IMWG criteria
Measured: up to 3 years
Very good partial response (VGPR) rate according to IMWG criteria
Measured: up to 3 years
Duration of response
Measured: up to 3 years
Progression-free survival
Measured: up to 3 years
Time to progression
Measured: up to 3 years
Time to response
Measured: up to 3 years
Overall survival
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start21 Dec 2023
- Primary completionJan 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296121
- Sponsor's protocol ID
- BCD-264-2
- Acronym
- DARVIVA
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06296121
- Acronym / sponsor ID
- DARVIVA / BCD-264-2
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-264 | Experimental | Drug: BCD-264Blinded 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 |
| Darzalex | Active comparator | Drug: DarzalexBlinded 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent form.
- Age ≥ 18 years at the time of signing of the informed consent form.
- Documented diagnosis of multiple myeloma according to IMWG criteria
- Measurable disease at screening:
- At least a partial response according to IMWG criteria to at least 1 prior line of therapy.
Key exclusion criteria (11 listed)
- Prior treatment with daratumumab or other anti-CD38 therapy.
- Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
- Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
- Allogeneic hematopoietic stem cell transplantation, regardless of timing.
- Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-264Also: daratumumabIV, 16 mg/kg | Drug | BCD-264 |
| DarzalexAlso: daratumumabIV, 16 mg/kg | Drug | Darzalex |
Primary outcome
Overall response rate according to IMWG (International Myeloma Working Group) criteria
Time frame: up to 24 weeks
8 secondary outcomes
Stringent complete response rate according to IMWG criteria
Time frame: up to 3 years
Complete response (CR) rate according to IMWG criteria
Time frame: up to 3 years
Very good partial response (VGPR) rate according to IMWG criteria
Time frame: up to 3 years
Duration of response
Time frame: up to 3 years
Progression-free survival
Time frame: up to 3 years
Time to progression
Time frame: up to 3 years
Time to response
Time frame: up to 3 years
Overall survival
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuzbass Regional Clinical Hospital named after S.V. Belyaev
Kemerovo, Russia
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-264 and Darzalex in people with Multiple Myeloma, run by Biocad at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate according to IMWG (International Myeloma Working Group) criteria (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.