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Refractory Multiple Myeloma Pipeline Analysis 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102700
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 the publisher 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 the publisher 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

By Drug Class

  • Monoclonal Antibodies
  • Antibody-Drug Conjugates
  • Bispecific T-cell Engagers (BiTEs) and Bispecific Antibodies
  • CAR-T Cell Therapies
  • Small Molecules
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Refractory Multiple Myeloma Pipeline Assessment Segmentation, By Phases

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 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 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

Refractory Multiple Myeloma - Emerging Drugs Profile

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?

Reasons To Buy This Report

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.

This product will be delivered within 3-5 business days.

Table of Contents

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 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 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 Region16 Terminated or Suspended Pipeline Products