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Methods of treating multiple myeloma

A technology of multiple myeloma and therapy, applied in the direction of chemical instruments and methods, biochemical equipment and methods, antineoplastic drugs, etc., can solve the unmet medical needs of the treatment of patients with limited survival, incurable, and double refractory And other issues

Pending Publication Date: 2022-02-08
SANOFI AVENTIS US LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, once patients become refractory to these agents, survival is limited, and in patients who respond to stem cell transplantation (SCT), chemotherapy, proteasome inhibitors, and immunomodulatory drugs Newer treatment options are needed to heal them after having experienced failure
Despite dramatic improvements in patient outcomes with newer therapies, MM remains an incurable disease
Therefore, patients who have received at least 2 different lines of therapy (including proteasome inhibitors and immunomodulators) or those who have received proteasome inhibitors and Treatment of patients who are doubly refractory remains an unmet medical need

Method used

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  • Methods of treating multiple myeloma
  • Methods of treating multiple myeloma
  • Methods of treating multiple myeloma

Examples

Experimental program
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Effect test

Embodiment 1

[0123]Example 1: Comparison of Isatuximab (SAR650984) in Combination with Pomalidomide and Low Dose Dexamethasone with Pomadol in Patients with Refractory or Relapsed and Refractory Multiple Myeloma A phase III randomized, open-label, multicenter study of amine and low-dose dexamethasone

[0124] This example describes a phase III, multicenter, multinational, randomized, open-label, parallel-group, 2-arm study that evaluated the combination of isatuximab with pomalidomide and low-dose dexamethasone versus Efficacy of pomalidomide versus low-dose dexamethasone for the treatment of patients with refractory or relapsed and refractory multiple myeloma who have received at least 2 prior lines of therapy (e.g., ≥2 prior lines of therapy), including lenalidomide and a proteasome inhibitor (e.g., bortezomib, carfilzomib, or ixazomib), given alone or in combination, and at Has demonstrated disease progression (eg, refractory to last therapy) on or within 60 days of completion of last ...

Embodiment 2

[0419] Example 2: Combination of isatuximab (SAR650984) with pomalidomide and low dose dexamethasone compared to pomalidomide in patients with refractory or relapsed and refractory multiple myeloma A subgroup analysis of East Asian patients in a phase III randomized, open-label, multicentre study of idomide and low-dose dexamethasone.

[0420] This example describes a subgroup analysis of East Asian patients in the Phase III, multicenter, multinational, randomized, open-label, parallel-group, 2-arm study described in Example 1. This subgroup analysis evaluated the combination of isatuximab with pomalidomide and low-dose dexamethasone compared with pomalidomide and low-dose dexamethasone for the treatment of patients with refractory or relapsed and refractory Safety and efficacy in East Asian patients with refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy for multiple myeloma (e.g., ≥2 prior lines of therapy), including or lenalidomide and ...

Embodiment 3

[0438]Example 3: Depth of Response and Response Kinetics in a Study of Isatuximab + Pomalidomide + Dexamethasone in Patients with Relapsed / Refractory Multiple Myeloma

[0439] In multiple myeloma (MM), deep responses have been associated with improvements in progression-free survival (PFS) and overall survival (OS). Reaction kinetic data (including renal reaction times), which are important in patients with renal impairment (RI), are rarely reported. Data from the randomized, open-label, active-controlled, phase 3 study described in Example 1 were used to analyze the association between depth of response (including minimal residual disease (MRD) negativity) plus response kinetics and long-term outcomes.

[0440] method

[0441] All patients received the standard dose of pomalidomide + dexamethasone ("Pd") as described in Example 1, and patients randomized to the Isa-Pd arm were on Days 1, 8, 15, and 22 ( Cycle 1) and received Pd with 10 mg / kg estatuximab IV on Days 1 and 1...

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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.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority from: European Patent Application No. 19306554.7, filed December 3, 2019; U.S. Provisional Application No. 62 / 943,716, filed December 4, 2019; Application No. 62 / 931,014; U.S. Provisional Application No. 62 / 899,094, filed September 11, 2019; U.S. Provisional Application No. 62 / 861,954, filed June 14, 2019; U.S. Provisional Application No., filed May 14, 2019 62 / 847,826; U.S. Provisional Application No. 62 / 797,876 filed January 28, 2019; the contents of each of which are incorporated herein by reference in their entirety. [0003] Submission of sequence listings in ASCII text files [0004] The contents of the following submitted ASCII text file are hereby incorporated by reference in their entirety: Computer Readable Form of the Sequence Listing (CRF) (File Name: 183952031241SEQLIST.txt, Date of Record: January 23, 2020, Size: 11 KB) . technical field [0005] The presen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/28A61K38/00A61K39/395A61P35/00A61K39/00
CPCC07K16/2896A61K39/395A61K2300/00A61K2039/54A61K2039/545A61K2039/505C07K2317/24A61P35/00A61K31/573A61K9/0019A61K47/26A61K47/183A61K9/48A61K9/20A61K31/454A61K31/69C12Q1/6869A61K39/3955A61K9/08A61K39/39591A61K47/22A61K47/12A61K47/02
Inventor F·坎帕纳·詹布拉诺H·奥德A·博尼斯特贝S·汇乐S·勒盖内克L·马纳切·阿尔伯里
Owner SANOFI AVENTIS US LLC