Summary
Bortezomib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Multiple Myeloma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Multiple Myeloma. ClinicalTrials.gov lists 8 registered trials linking Bortezomib to Multiple Myeloma: 1 is active or not yet recruiting; 3 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT07671287). It plans or enrolled 399 participants. Registration activity spans 2007 to 2026. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2014 to 2018. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Multiple Myeloma ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Essentially zero; MGUS (precursor) progresses to myeloma in 1%/year; median survival without treatment <1 year once symptomatic.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 43.0 (trials 19.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 3 completed, 4 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | CCND1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT07671287 | GMMG-HD11/DSMM XXI/64007957MMY3010 2026 | not yet recruiting | Phase 3 | 399 |
| NCT01470131 | A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma 2011 | terminated | Phase 3 | 147 |
| NCT00872352 | Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients 2009 | status unknown | Phase 3 | 30 |
| NCT02513186 | Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation 2015 | completed | Phase 1 | 90 |
| NCT03344328 | Prevalence, Intensity and Consequences of Bortezomib-induced Neuropathic Disorders. 2019 | completed | Not applicable | 67 |
| NCT00536575 | Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients 2007 | completed | PHASE1, PHASE2 | 13 |
| NCT02928029 | Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma 2017 | terminated | PHASE1, PHASE2 | 7 |
| NCT03089411 | Collection of Additional Data Followed the Study IFM 2013-04 2017 | status unknown | Not applicable | 340 |
Published literature
- Clinical trial publication Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 studyMoreau P, Mateos MV, Berenson JR et al. · The Lancet. Oncology · 2018 · PMID 29866475
- Clinical trial publication Changes in osteoblastic activity in patient who received bortezomib as second line treatment for plasma cell myeloma: a prospective multicenter studyEom KS, Kim SJ, Lee JJ et al. · BioMed research international · 2014 · PMID 25050331
Mechanism and notes
Recorded mechanism or class: inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CCND1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Bortezomib approved for Multiple Myeloma?
Bortezomib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Multiple Myeloma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Multiple Myeloma. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Bortezomib in clinical trials for Multiple Myeloma?
ClinicalTrials.gov lists 8 registered trials linking Bortezomib to Multiple Myeloma: 1 is active or not yet recruiting; 3 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT07671287). It plans or enrolled 399 participants. Registration activity spans 2007 to 2026.
What does the evidence show for Bortezomib in Multiple Myeloma?
Bortezomib has 3 completed trials and 2 linked publications for Multiple Myeloma. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CCND1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.