Multiple Myeloma
Recent clinical, regulatory, research and industry developments relating to this disease.
Market withdrawal: Celdoxome pegylated liposomal (EMA)
Market withdrawal: Bortezomib Hospira (EMA)
Approval: Pomalidomide Teva (EMA)
Deciphering the genetics and mechanisms of predisposition to multiple myeloma.
Approval: Pomalidomide Accord (EMA)
A systematic review and meta-analysis of nonrelapse mortality after CAR T cell therapy.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 4 clinical trials expected to report results, the earliest in Q4 2027.
- 2 safety actions from EMA issued.
- Q4 2027A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
- Q1 2029A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
- Q1 2029A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
- Q2 2033A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Clinical MilestonesView all 14Hide
- 2026-06-23A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell TransplantResults posted
- 2026-06-08A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple MyelomaResults posted
- 2026-06-02A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial TherapyResults posted
- 2026-07-06A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial TherapyResults expected Q1 2029
- 2026-07-02A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)Results expected Q1 2029
- 2026-04-03A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)Results expected Q4 2027
- 2026-03-17A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant EligibleResults expected Q2 2033
- 2026-07-18A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2Primary completion
- 2026-04-13A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)Completed
- 2025-10-13A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and LenalidomidePrimary completion
- 2038-05-21A Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple MyelomaWithdrawn
- 2030-09-21A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMMWithdrawn
- 2029-05-01An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell TransplantationWithdrawn
- 2026-12-31An Open-Label, Non-Comparative, Two-Cohort, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Pomalidomide and Dexamethasone (IPd, Cohort A) or With Lenalidomide and Dexamethasone (IRd, Cohort B) in Patients With Relapsed/Refractory Multiple Myeloma Previously Receiving a Parenteral Proteasome Inhibitor-based Treatment Regimen (US MM-7)Withdrawn
Regulatory UpdatesViewHide
- 2025-09-22Market withdrawal — DoxorubicinCeldoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
- 2025-08-07Market withdrawal — BortezomibBortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
- 2038-05-21ClinicalA Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple MyelomaWithdrawn
- 2030-09-21ClinicalA Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMMWithdrawn
- 2029-05-01ClinicalAn Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell TransplantationWithdrawn
- 2026-12-31ClinicalAn Open-Label, Non-Comparative, Two-Cohort, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Pomalidomide and Dexamethasone (IPd, Cohort A) or With Lenalidomide and Dexamethasone (IRd, Cohort B) in Patients With Relapsed/Refractory Multiple Myeloma Previously Receiving a Parenteral Proteasome Inhibitor-based Treatment Regimen (US MM-7)Withdrawn
- 2026-07-18ClinicalA Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2Primary completion
- 2026-07-06ClinicalA Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial TherapyResults expected Q1 2029
- 2026-07-02ClinicalA Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)Results expected Q1 2029
- 2026-06-23ClinicalA Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell TransplantResults posted
- 2026-06-08ClinicalA Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple MyelomaResults posted
- 2026-06-02ClinicalA Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial TherapyResults posted
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myelo… (2025)
Approval — Monotherapy for the treatment of adult patients with relapsed or refractory multiple myel… (2025)
Approval — Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the tr… (2024)
Approval — Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed an… (2023)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Multiple Myeloma10
- Immunotherapy, Adoptive5
- Receptors, Chimeric Antigen5
- Neurotoxicity Syndromes2
- B-Cell Maturation Antigen1
- DNA Copy Number Variations1
- Genetic Predisposition to Disease1
- Genome-Wide Association Study1
Leading journals6
- The New England journal of medicine5
- Frontiers in immunology3
- Journal of hematology & oncology3
- Nature communications2
- Blood1
- Blood cancer journal1
Leading researchers8
- Anderson KC4
- Jagannath S4
- Madduri D4
- Berdeja J3
- Einsele H3
- Jakubowiak A3
- Lin Y3
- Lonial S3
Affiliations (unnormalised)6
- Dana-Farber Cancer Institute3
- Memorial Sloan Kettering Cancer Center3
- Abramson Cancer Center2
- Harvard Medical School2
- Lincoln Medical Center2
- Mount Sinai Medical Center2
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Multiple myeloma is a malignancy of mature plasma cells that produces a monoclonal immunoglobulin. It is characterized by excess monoclonal light chains in the urine, skeletal destruction, bone pain, fractures, anemia, hypercalcemia, and renal insufficiency.
The supplied grounding supports an etiologic focus on genetics, but it does not specify a particular cause or causal pathway. No additional cause is supported here.
The disease arises from malignant plasma cells that engage in monoclonal immunoglobulin production. The literature grounding also highlights immune and antigen-directed biology, including CD38 and BCMA expression on myeloma cells and the use of CAR T cells, monoclonal antibodies, antibody-drug conjugates, and bispecific T-cell engagers to target these cells.
The supplied grounding does not identify specific risk factors for developing multiple myeloma. It only indicates that the literature covers genetics, immunology, mortality, complications, therapy, drug therapy, and etiology.
Treatment is described at the modality and drug-class level as immunotherapy and drug therapy for relapsed or refractory disease, including thalidomide, lenalidomide, and elotuzumab. The grounding also supports CD38-targeting monoclonal antibodies, BCMA-targeted therapies such as CAR T cells, antibody-drug conjugates, and bispecific T-cell engagers.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.