Refractory multiple myeloma is a form of blood cancer that becomes resistant to standard treatments, making it difficult to manage. It accounts for a significant and increasing proportion of multiple myeloma cases. The average lifetime risk of developing multiple myeloma in the United States is less than 1%, with a risk of about 1 in 108 for men and 1 in 133 for women. The pipeline for refractory multiple myeloma is witnessing notable growth, with a strong focus on CAR-T cell therapies, bispecific antibodies, and novel immunotherapies. The refractory multiple myeloma pipeline analysis by Expert Market Research emphasizes the rising R&D activities and advanced treatment options driving the treatment market expansion.
Report Coverage
The Refractory Multiple Myeloma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into refractory multiple myeloma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for refractory multiple myeloma. The refractory multiple myeloma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The refractory multiple myeloma pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with refractory multiple myeloma treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to refractory multiple myeloma.
Refractory Multiple Myeloma Pipeline Outlook
Refractory multiple myeloma is a type of blood cancer where malignant plasma cells resist standard treatments. It often develops when patients no longer respond to therapies such as proteasome inhibitors, immunomodulatory agents, or monoclonal antibodies. This resistance may emerge after several treatment cycles or during relapse, complicating disease control and requiring alternative or advanced treatment options.
Refractory multiple myeloma is treated with targeted therapies, immunotherapies, CAR-T cell therapies, or antibody-drug conjugates to help overcome resistance and prolong patient survival. In April 2024, Carvykti (ciltacabtagene autoleucel) received U.S. FDA approval for earlier-line treatment in relapsed or refractory multiple myeloma, reducing disease progression risk by 59% in the Phase 3 CARTITUDE-4 study.
Refractory Multiple Myeloma Epidemiology
Refractory multiple myeloma remains a critical challenge in oncology, with an increasing incidence of multiple myeloma among aging populations. According to the American Cancer Society, an estimated 36,110 new cases of multiple myeloma and 12,030 deaths due to multiple myeloma are expected in the United States in 2025. The average age at diagnosis is 69 years. A 2023 study from Japan reported multiple myeloma incidence rising from 5.9 to 6.1 per 100,000 from 2016- 2020, with an average diagnosis age of 67 years.
Refractory Multiple Myeloma – Pipeline Therapeutic Assessment
This section of the report covers the analysis of refractory multiple myeloma drug candidates based on several segmentations, including:
By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
- Monoclonal Antibodies
- Antibody-Drug Conjugates
- Bispecific T-cell Engagers (BiTEs) and Bispecific Antibodies
- CAR-T Cell Therapies
- Small Molecules
- Others
- Oral
- Parenteral
- Others
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis , phase II covers a major share of the total refractory multiple myeloma clinical trials, with 49.06%, underscoring a strong emphasis on mid-stage clinical development and therapeutic validation. The remaining pipeline is comprised of phase I at 47.88%, early phase I at 5.07%, phase III at 7.23%, and phase IV at 0.47%. This reflects robust research momentum and continued innovation, positively shaping the future of the refractory multiple myeloma pipeline.
Refractory Multiple Myeloma Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the refractory multiple myeloma pipeline analysis include monoclonal antibodies, antibody-drug conjugates, bispecific T-cell engagers (BiTEs) and bispecific antibodies, CAR-T cell therapies, small molecules, and others. The refractory multiple myeloma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for refractory multiple myeloma.
B-cell lymphoma 2 (BCL-2) inhibitors are being explored as a promising drug class in the treatment of relapsed or refractory multiple myeloma. For instance, ABBV-453, an oral small molecule inhibitor targeting BCL-2, is currently undergoing clinical development. It aims to induce apoptosis in malignant plasma cells, potentially improving outcomes in heavily pretreated patients.
Refractory Multiple Myeloma Clinical Trials – Key Players
The EMR report for the refractory multiple myeloma pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed refractory multiple myeloma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in refractory multiple myeloma clinical trials:
- Regeneron Pharmaceuticals
- AbbVie
- Novartis Pharmaceuticals
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Nanjing Leads Biolabs Co.,Ltd.
- Hangzhou Sumgen Biotech Co., Ltd.
- Sanofi
- Cullinan Therapeutics Inc.
- Celgene
- Biocad
- Allogene Therapeutics
- AstraZeneca
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for refractory multiple myeloma. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of refractory multiple myeloma drug candidates.
Drug: BMS-986393
BMS-986393 is a GPRC5D-directed autologous CAR-T cell therapy sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. This Phase 3 study is evaluating its efficacy and safety compared to standard regimens in relapsed or refractory and lenalidomide-refractory multiple myeloma. The trial aims to determine therapeutic benefit, durability of response, and overall tolerability in heavily pretreated patients.
Biological: PHE885
PHE885, sponsored by Novartis Pharmaceuticals, is a BCMA-directed CAR-T cell therapy developed using the T-Charge platform. It is a part of a Phase II study, where it is being evaluated for its efficacy and safety in adult patients with relapsed and refractory multiple myeloma. The trial is examining the overall response rate in 90 evaluable patients after at least three prior therapies, with ongoing recruitment and long-term monitoring planned.
Drug: REGN5459
REGN5459 is a BCMA × CD3 bispecific antibody sponsored by Regeneron Pharmaceuticals. It is currently undergoing a Phase 1/2 trial in adults with relapsed or refractory multiple myeloma. This study is evaluating the drug’s safety, tolerability, and anti-tumor activity. REGN5459 is designed to provide deep responses with reduced cytokine release syndrome risk due to its low CD3 affinity.
Key Questions Answered in the Refractory Multiple Myeloma Pipeline Analysis Report
- Which companies/institutions are leading the refractory multiple myeloma drug development?
- What is the efficacy and safety profile of refractory multiple myeloma pipeline drugs?
- Which company is leading the refractory multiple myeloma pipeline development activities?
- What is the current refractory multiple myeloma commercial assessment?
- What are the opportunities and challenges present in the refractory multiple myeloma pipeline landscape?
- What is the efficacy and safety profile of refractory multiple myeloma pipeline drugs?
- Which company is conducting major trials for refractory multiple myeloma drugs?
- Which companies/institutions are involved in refractory multiple myeloma collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in refractory multiple myeloma?
The Refractory Multiple Myeloma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for refractory multiple myeloma. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into refractory multiple myeloma collaborations, regulatory environments, and potential growth opportunities.
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- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Refractory Multiple Myeloma
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Refractory Multiple Myeloma
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Refractory Multiple Myeloma: Epidemiology Snapshot
- 5.1 Refractory Multiple Myeloma Incidence by Key Markets
- 5.2 Refractory Multiple Myeloma – Patients Seeking Treatment in Key Markets
- 6 Refractory Multiple Myeloma: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Refractory Multiple Myeloma: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Refractory Multiple Myeloma, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Refractory Multiple Myeloma Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Refractory Multiple Myeloma Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
- 10.1 Comparative Analysis for Late-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: SG301
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Biological: bb2121
- 10.2.3 Drug: BCD-264 and Darzalex
- 10.2.4 Drug: BMS-986393
- 10.2.5 Other Drugs
- 11 Refractory Multiple Myeloma Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: GR1803 Injection
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Biological: PHE885
- 11.2.3 Drug: REGN5459
- 11.2.4 Drug: LBL-034 for Injection
- 11.2.5 Other Drugs
- 12 Refractory Multiple Myeloma Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Drug: ABBV-453
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Drug: CLN-619
- 12.2.3 Other Drugs
- 13 Refractory Multiple Myeloma Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
- 13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
- 13.1.1 Study Type
- 13.1.2 Recruitment Status
- 13.1.3 Company
- 13.1.4 Funder Type
- 13.2 Product Level Analysis*
- 13.2.1 Drug 1
- 13.2.1.1 Product Description
- 13.2.1.2 Trial ID
- 13.2.1.3 Sponsor Name
- 13.2.1.4 Study Type
- 13.2.1.5 Drug Class
- 13.2.1.6 Eligibility Criteria
- 13.2.1.7 Study Record Dates
- 13.2.1.7.1 First Submitted
- 13.2.1.7.2 First Posted
- 13.2.1.7.3 Last Update Posted
- 13.2.1.7.4 Last Verified
- 13.2.1.8 Indication
- 13.2.1.9 Study Design
- 13.2.1.10 Recruitment Status
- 13.2.1.11 Enrollment (Estimated)
- 13.2.1.12 Location Countries
- 13.2.2 Other Drugs
- 14 Refractory Multiple Myeloma, Key Drug Pipeline Companies
- 14.1 Regeneron Pharmaceuticals
- 14.1.1 Company Snapshot
- 14.1.2 Pipeline Product Portfolio
- 14.1.3 Financial Analysis
- 14.1.4 Recent News and Developments
- 14.2 AbbVie
- 14.2.1 Company Snapshot
- 14.2.2 Pipeline Product Portfolio
- 14.2.3 Financial Analysis
- 14.2.4 Recent News and Developments
- 14.3 Novartis Pharmaceuticals
- 14.3.1 Company Snapshot
- 14.3.2 Pipeline Product Portfolio
- 14.3.3 Financial Analysis
- 14.3.4 Recent News and Developments
- 14.4 Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- 14.4.1 Company Snapshot
- 14.4.2 Pipeline Product Portfolio
- 14.4.3 Financial Analysis
- 14.4.4 Recent News and Developments
- 14.5 Nanjing Leads Biolabs Co.,Ltd.
- 14.5.1 Company Snapshot
- 14.5.2 Pipeline Product Portfolio
- 14.5.3 Financial Analysis
- 14.5.4 Recent News and Developments
- 14.6 Hangzhou Sumgen Biotech Co., Ltd.
- 14.6.1 Company Snapshot
- 14.6.2 Pipeline Product Portfolio
- 14.6.3 Financial Analysis
- 14.6.4 Recent News and Developments
- 14.7 Sanofi
- 14.7.1 Company Snapshot
- 14.7.2 Pipeline Product Portfolio
- 14.7.3 Financial Analysis
- 14.7.4 Recent News and Developments
- 14.8 Cullinan Therapeutics Inc.
- 14.8.1 Company Snapshot
- 14.8.2 Pipeline Product Portfolio
- 14.8.3 Financial Analysis
- 14.8.4 Recent News and Developments
- 14.9 Celgene
- 14.9.1 Company Snapshot
- 14.9.2 Pipeline Product Portfolio
- 14.9.3 Financial Analysis
- 14.9.4 Recent News and Developments
- 14.10 Biocad
- 14.10.1 Company Snapshot
- 14.10.2 Pipeline Product Portfolio
- 14.10.3 Financial Analysis
- 14.10.4 Recent News and Developments
- 14.11 Allogene Therapeutics
- 14.11.1 Company Snapshot
- 14.11.2 Pipeline Product Portfolio
- 14.11.3 Financial Analysis
- 14.11.4 Recent News and Developments
- 14.12 AstraZeneca
- 14.12.1 Company Snapshot
- 14.12.2 Pipeline Product Portfolio
- 14.12.3 Financial Analysis
- 14.12.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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