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

Multiple Myeloma Clinical Trial

— DARVIVA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296121
• Other study ID #: BCD-264-2
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2023
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: July 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?/? 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• BCD-264
IV, 16 mg/kg
• Darzalex
IV, 16 mg/kg

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Regional Clinical Hospital	Chelyabinsk
Russian Federation	Sverdlovsk Regional Clinical Hospital No. 1	Ekaterinburg
Russian Federation	Kuzbass Regional Clinical Hospital named after S.V. Belyaev	Kemerovo
Russian Federation	Regional Clinical Hospital	Krasnoyarsk
Russian Federation	Moscow City Clinical Hospital 52	Moscow
Russian Federation	S.P. Botkin Moscow City Clinical Hospital	Moscow
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg
Russian Federation	N.N. Petrov National Medicine Research Center of oncology	Saint Petersburg
Russian Federation	Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency	Saint Petersburg
Russian Federation	St Petersburg State I.P. Pavlov Medical University	Saint Petersburg
Russian Federation	State budgetary healthcare institution Leningrad Regional Clinical Hospital	Saint Petersburg
Russian Federation	Samara State Medical University	Samara
Russian Federation	Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory	Sochi
Russian Federation	Bashkir State Medical University	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and characteristics of adverse events		up to 2 years
Other	Proportion of subjects with BAbs/Nabs		up to 2 years
Other	Time to BAb/NAb development		up to 2 years
Other	AUC0-168		up to Day 8 Cycle 1 (each cycle is 28 days)
Other	AUC0-8		up to Day 15 Cycle 6 (each cycle is 28 days)
Other	AUC0-336, ss		from Day 1 to Day 15 Cycle 6 (each cycle is 28 days)
Other	Cmax		up to Day 15 Cycle 6 (each cycle is 28 days)
Other	Cmax, ss		up to Day 15 Cycle 6 (each cycle is 28 days)
Other	Tmax		up to Day 15 Cycle 6 (each cycle is 28 days)
Other	T1/2		up to Day 15 Cycle 6 (each cycle is 28 days)
Other	Vd		up to Day 15 Cycle 6 (each cycle is 28 days)
Other	Ctrough, ss		up to Day 15 Cycle 6 (each cycle is 28 days)
Primary	Overall response rate according to IMWG (International Myeloma Working Group) criteria		up to 24 weeks
Secondary	Stringent complete response rate according to IMWG criteria		up to 3 years
Secondary	Complete response (CR) rate according to IMWG criteria		up to 3 years
Secondary	Very good partial response (VGPR) rate according to IMWG criteria		up to 3 years
Secondary	Duration of response		up to 3 years
Secondary	Progression-free survival		up to 3 years
Secondary	Time to progression		up to 3 years
Secondary	Time to response		up to 3 years
Secondary	Overall survival		up to 3 years