Venetoclax and Dexamethasone in translocation (11;14) positive relapsed and refractory multiple myeloma (VICTORIA)

Conditions

multiple myeloma

Brief summary

To evaluate the overall response rate (partial response or better) of the combination of Venetoclax-dexamethasone in patients with relapsed or refractory multiple myeloma

Detailed description

progression-free survival, clinical benefit rate (minimal response or better), time to next treatment, overall survival, time to response, duration of response, safety and tolerability, discontinuation rate, quality of life, number of serious adverse events due to infections, duration of hospital admissions due to infections, effect of PET-positivity on efficacy end-points, Estimation of humoral immunodeficiency of subjects at baseline by measuring serum anti-pneumococcal polysaccharide IgG, IgA, IgM antibodies, assessment of the relation of humoral immunodeficiency to infections, assessment of pneumococcal vaccination response and its relation to infections, estimation of Bcl-2 overexpression by immunohistochemistry, assessment of the relation of Bcl-2 overexpression to the efficacy of the study treatment

Related papers

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Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGVENETOCLAX

DRUGPrevenar 13 suspension for injection in single dose vial pneumococcal polysaccharide conjugate vaccine (13-valent

DRUGadsorbed)

DRUGDexamethasone 4 mg tablets

DRUGPneumovax

DRUGinjektionsvæske

DRUGopløsning i fyldt injektionssprøjte

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the overall response rate (partial response or better) of the combination of Venetoclax-dexamethasone in patients with relapsed or refractory multiple myeloma	—

Secondary

Measure	Time frame
progression-free survival, clinical benefit rate (minimal response or better), time to next treatment, overall survival, time to response, duration of response, safety and tolerability, discontinuation rate, quality of life, number of serious adverse events due to infections, duration of hospital admissions due to infections, effect of PET-positivity on efficacy end-points, Estimation of humoral immunodeficiency of subjects at baseline by measuring serum anti-pneumococcal polysaccharide IgG, IgA, IgM antibodies, assessment of the relation of humoral immunodeficiency to infections, assessment of pneumococcal vaccination response and its relation to infections, estimation of Bcl-2 overexpression by immunohistochemistry, assessment of the relation of Bcl-2 overexpression to the efficacy of the study treatment	—

Measure

Time frame

progression-free survival, clinical benefit rate (minimal response or better), time to next treatment, overall survival, time to response, duration of response, safety and tolerability, discontinuation rate, quality of life, number of serious adverse events due to infections, duration of hospital admissions due to infections, effect of PET-positivity on efficacy end-points, Estimation of humoral immunodeficiency of subjects at baseline by measuring serum anti-pneumococcal polysaccharide IgG, IgA, IgM antibodies, assessment of the relation of humoral immunodeficiency to infections, assessment of pneumococcal vaccination response and its relation to infections, estimation of Bcl-2 overexpression by immunohistochemistry, assessment of the relation of Bcl-2 overexpression to the efficacy of the study treatment

—

Countries

Denmark

Outcome results

None listed