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NCT01440582
Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients
Phase 1 trial testing Panobinostat in Myeloma in 77 participants. Completed in 28 February 2019.
28 February 2019
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 18 February 2013 |
| Primary completion | 28 February 2019 |
| Estimated completion | 28 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Panobinostat (PANOBINOSTAT) — full drug profile →
- Bortezomib (bortezomib) — full drug profile →
- Lenalidomide — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Symptom Questionnaire
Conditions studied
- Myeloma — all drugs for Myeloma →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical research study is to find the highest tolerable dose of the drug panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug combination will also be studied. Panobinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may slow the growth of cancer cells. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting Histone Deacetylases in Diseases: Where Are We?
Benedetti R, Conte M, Altucci L. · · 2015 · cited 91× · PMID 24382114 · DOI 10.1089/ars.2013.5776 -
Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6 -
Exploring the role of histone deacetylase and histone deacetylase inhibitors in the context of multiple myeloma: mechanisms, therapeutic implications, and future perspectives.
Pu J, Liu T, Wang X, Sharma A, et al · · 2024 · cited 36× · PMID 38654286 · DOI 10.1186/s40164-024-00507-5 -
The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift?
Kazandjian D, Mo CC, Landgren O, Richardson PG. · · 2020 · cited 25× · PMID 32501533 · DOI 10.1111/bjh.16764 -
Posttransplant maintenance therapy in multiple myeloma: the changing landscape.
Sengsayadeth S, Malard F, Savani BN, Garderet L, et al · · 2017 · cited 25× · PMID 28338672 · DOI 10.1038/bcj.2017.23 -
Bortezomib, lenalidomide, and dexamethasone with panobinostat for front-line treatment of patients with multiple myeloma who are eligible for transplantation: a phase 1 trial.
Manasanch EE, Shah JJ, Lee HC, Weber DM, et al · · 2018 · cited 14× · PMID 30501870 · DOI 10.1016/s2352-3026(18)30174-1 -
Investigating the Interplay between Myeloma Cells and Bone Marrow Stromal Cells in the Development of Drug Resistance: Dissecting the Role of Epigenetic Modifications.
Schütt J, Nägler T, Schenk T, Brioli A. · · 2021 · cited 8× · PMID 34439223 · DOI 10.3390/cancers13164069 -
Clinical developments in the treatment of relapsed or relapsed and refractory multiple myeloma: impact of panobinostat, the first-in-class histone deacetylase inhibitor.
Redic KA, Hough SM, Price EM. · · 2016 · cited 8× · PMID 27274274 · DOI 10.2147/ott.s87962
Verify or expand the search:
- PubMed search for NCT01440582
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT03878524 — Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial · Phase 1 · terminated
- NCT04897880 — A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT · Phase 2 · terminated
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01440582 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 4 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01440582.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing