Data updated: May 26, 2026
VELCADE (bortezomib)
Proteasome Inhibitors
Trial Activity: Stable 116 active trials
Oncology
Approved 2003-05-13
VELCADE is indicated for the treatment of Multiple Myeloma; Mantle Cell Lymphoma.
How VELCADE Works
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome, a protein complex responsible for degrading ubiquitinated proteins. By inhibiting this targeted proteolysis, the drug disrupts cellular homeostasis and multiple signaling cascades, leading to cytotoxicity in cancer cells and a delay in tumor growth.
Development Insights
National Cancer Institute (NCI) conducting 27 trials (7%)
435 indications explored (Broad Platform)
→ multiple myeloma (167 trials)
→ lymphoma (14 trials)
→ acute myeloid leukemia (13 trials)
12
Indications
--
Phase 3 Trials
7
Priority Reviews
23
Years on Market
Details
- Status
- Prescription
- First Approved
- 2003-05-13
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
VELCADE Approval History
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
31 FDA actions from 2003 to 2021 · 11 indication expansions
Aug 2015 SUPPL Priority
Mfg
Sep 2014 SUPPL Priority
Mfg
Mar 2014 SUPPL Priority
Mfg
Aug 2013 SUPPL Priority
Mfg
Aug 2013 SUPPL Priority
Mfg
Apr 2013 SUPPL Priority
Mfg
Apr 2011 SUPPL
Label
What VELCADE Treats
2 indicationsVELCADE is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
- Mantle Cell Lymphoma
Source: FDA Label
VELCADE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VELCADE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VELCADE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VELCADE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
LENALIDOMIDE
LENALIDOMIDE
ZYDUS PHARMS
Shared indications:
Multiple MyelomaMantle Cell Lymphoma
REVLIMID
LENALIDOMIDE
Bristol-Myers Squibb
Shared indications:
Multiple MyelomaMantle Cell Lymphoma
📋
Clinical Trial Registry
399 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01009840 results posted | 273-08-205 | Ph 2 | completed | IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients |
| NCT06169215 | NCI-2023-07073 NCI-2023-07073, 10612 | Ph 2 | active not recruiting | Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma |
| NCT05514990 | 16M-22-1 NCI-2022-06505, 16M-22-1 | Ph 1, Ph 2 | active not recruiting | Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial |
| NCT06152575 | C1071032 MAGNETISMM-32, 2023-507871-23-00 | Ph 3 | recruiting | MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) |
| NCT05849610 GEM-TECTAL | GEM-TECTAL | Ph 2 | active not recruiting | Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma |
| NCT04181827 CARTITUDE-4 results posted | CR108695 68284528MMY3002, 2019-001413-16 | Ph 3 | active not recruiting | A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma |
| NCT00871013 | 108053 | Ph 2 | active not recruiting | Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy |
| NCT05083169 MajesTEC-3 | CR109049 64007957MMY3001, 2020-004742-11 | Ph 3 | active not recruiting | A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04923893 CARTITUDE-5 | CR109015 68284528MMY3004, 2021-001242-35 | Ph 3 | active not recruiting | A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy |
| NCT07222761 LINKER-MM5 | R5458-ONC-2246 2024-519504-27-00 | Ph 3 | recruiting | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT06577025 aMMbition | 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 | Ph 2 | active not recruiting | A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma |
| NCT04722146 MajesTEC-2 | CR108927 64007957MMY1004, 2020-004404-33 | Ph 1 | active not recruiting | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT00720785 | 080186 08-H-0186 | Ph 1 | completed | Natural Killer Cells and Bortezomib to Treat Cancer |
| NCT06413498 iMMagine-3 | KT-US-679-0788 2024-511188-26, jRCT2043240170 | Ph 3 | recruiting | A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma |
| NCT06022939 | S2213 NCI-2023-04234, S2213 | Ph 3 | recruiting | Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis |
| NCT04566328 | EAA181 NCI-2020-06647, EAA181 | Ph 3 | recruiting | Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial |
| NCT05623020 MagnetisMM-6 | C1071006 MAGNETISMM-6, 2024-514139-50-00 | Ph 3 | recruiting | A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant |
| NCT06348147 | LCCC2323 | Ph 2 | suspended | Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02343042 STOMP | KCP-330-017 | Ph 1, Ph 2 | active not recruiting | Selinexor and Backbone Treatments of Multiple Myeloma Patients |
| NCT03319667 IMROZ | EFC12522 U1111-1194-2121, 2024-514417-34 | Ph 3 | active not recruiting | A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant |
| NCT06390319 | SJALL23T NCI-2024-03015 | Ph 2 | recruiting | Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) |
| NCT05519085 SUCCESSOR-1 | CA057-001 2023-509859-13 | Ph 3 | recruiting | A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) |
| NCT07391657 DURGA-4 | D8311C00001 AZD0120 | Ph 3 | recruiting | A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) |
| NCT07227311 | 224317 2025-523117-28-00 | Ph 2 | recruiting | A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM) |
| NCT01668719 results posted | S1211 NCI-2012-01998, PS1211_A12PAMDREVW01 | Ph 1, Ph 2 | completed | S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma |
| NCT02783625 | 16-042 | Ph 1 | completed | Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas |
| NCT06868654 DREAMM 7 results posted | 207503-CHN | Ph 3 | active not recruiting | China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| NCT06868667 DREAMM 7 results posted | 207503-JPN | Ph 3 | active not recruiting | Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| NCT03945591 results posted | 18-01185 | Ph 2 | completed | High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
| NCT04246047 DREAMM 7 results posted | 207503 2023-510537-28-00 | Ph 3 | active not recruiting | Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma |
| NCT05392946 | MC200807 21-006604 | Ph 1, Ph 2 | active not recruiting | Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study |
| NCT07513129 | 2025-1869 NCI-2026-02416 | Ph 1 | not yet recruiting | Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma |
| NCT05848687 | IRB-68271 PEDSHEMALL0015, NCI-2023-04129 | Ph 1, Ph 2 | recruiting | TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II |
| NCT04166565 EMN19 | EMN19 2019-000991-41 | Ph 2 | active not recruiting | Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease |
| NCT04996160 | IRB-60392 NCI-2021-09313 | Ph 1 | completed | Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia |
| NCT06083922 | 22-424 | Ph 2 | recruiting | A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS) |
| NCT03763162 | 2018-0512 NCI-2018-02830, 2018-0512 | Ph 2 | active not recruiting | Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma |
| NCT02719613 | CA204-185 2016-000037-51 | Ph 2 | completed | Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab |
| NCT01695941 | NCI-2012-01712 NCI-2012-01712, S12-02028 | Ph 1 | active not recruiting | Alisertib, Bortezomib, and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or B-cell Low Grade Non-Hodgkin Lymphoma |
| NCT00644228 results posted | NCI-2009-00798 NCI-2009-00798, SWOG-S0777 | Ph 3 | active not recruiting | Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma |
| NCT05250973 AQUARIUS | CR109160 54767414AMY2009, 2021-002639-48 | Ph 2 | active not recruiting | A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis |
| NCT04133636 CARTITUDE-2 | CR108581 68284528MMY2003, 2018-004124-10 | Ph 2 | active not recruiting | A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma |
| NCT05572515 MajesTEC-9 | CR109244 64007957MMY3006, 2022-000928-37 | Ph 3 | active not recruiting | A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT01861314 | NCI-2013-00999 NCI-2013-00999, OSU-11186 | Ph 1 | active not recruiting | Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia |
| NCT03984097 | TAK-079-1002 U1111-1230-4820 | Ph 1 | completed | A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) |
| NCT04433156 | HNSZLYYNHL03 | Ph 2 | completed | VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma |
| NCT05736419 | 23-009 | Ph 2 | recruiting | A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT) |
| NCT03652064 results posted | CR108529 54767414MMY3019, 2018-001545-13 | Ph 3 | active not recruiting | A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy |
| NCT04975997 EXCALIBER-RRMM | CC-220-MM-002 U1111-1260-2872, 2020-000431-49 | Ph 3 | active not recruiting | Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) |
Showing 50 of 399 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VELCADE FDA Label Details
Indications & Usage
FDA Label (PDF)VELCADE is indicated for the treatment of Multiple Myeloma; Mantle Cell Lymphoma.
Track VELCADE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment