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US 2024/0190984 A1Published application
Methods of treating multiple myeloma
AssigneeSanofi-Aventis U.S. LLC
InventorsHeloise AUDAT, Audrey BONESTEBE, Frank CAMPANA ZAMBRANO, Sylvain HUILLE, Solenn LE-GUENNEC, Lucie MANACHE-ALBERICI
Life of this patent
Estimating the term…
Abstract
The present disclosure provides methods for treating multiple myeloma (such as refractory multiple myeloma or relapsed and refractory multiple myeloma) in an individual who received at least two prior therapies for multiple myeloma. The methods comprise administering to the individual an anti-CD38 antibody, pomalidomide, and dexamethasone. Also provided are methods of improving renal impairment in an individual having multiple myeloma.
Claims6
1-2. (canceled)
3:
- A liquid pharmaceutical formulation comprising
- (a) isatuximab at a concentration of 5-20 mg/ml;
- (b) a buffering agent selected from the group consisting of:
- histidine, acetate, and phosphate;
- (c) an excipient selected from the group consisting of:
- sucrose and mannitol, and (d) polysorbate 80 (PS80).
3 more elements
4:
- The liquid pharmaceutical formulation of claim 3, wherein isatuximab is present at a concentration of 5 mg/ml, wherein the buffering agent is histidine and the histidine is at a concentration of 10 mM, wherein the excipient is sucrose and the sucrose is at a concentration of 10% (w/v), wherein the PS80 is present at a concentration of 0.005% (w/v), and wherein the pharmaceutical formulation has a pH of about 6.0 or about 6.5.
5:
- The liquid pharmaceutical formulation of claim 4, wherein the pH is about 6.5.
6:
- The liquid pharmaceutical formulation of claim 3, wherein isatuximab is present at a concentration of 20 mg/ml, wherein the buffering agent is histidine and the histidine is at a concentration of 20 mM, wherein the excipient is sucrose and the sucrose is present at a concentration of 10% (w/v), wherein the PS80 is present at a concentration of 0.02% (w/v), and wherein the pharmaceutical formulation has a pH of about 6.0.
7-60. (canceled)