NCT01464112

A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma

Completed Phase 1 Last updated 22 January 2020

What this trial tests

Phase 1 trial testing JNJ-2641585 / VELCADE / Dexamethasone in Multiple Myeloma in 18 participants. Completed in 19 November 2013.

Timeline

16 September 2011

Primary endpoint
19 November 2013

19 November 2013

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	16 September 2011
Primary completion	19 November 2013
Estimated completion	19 November 2013
Sites	3 locations across France

Drugs / interventions tested

• JNJ-2641585 / VELCADE / Dexamethasone — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 99, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
2. Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
   Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
3. Recent Update of HDAC Inhibitors in Lymphoma.
   Chen IC, Sethy B, Liou JP. · · 2020 · cited 60× · PMID 33015069 · DOI 10.3389/fcell.2020.576391
4. Small Molecules Targeting HATs, HDACs, and BRDs in Cancer Therapy.
   Wu D, Qiu Y, Jiao Y, Qiu Z, et al · · 2020 · cited 55× · PMID 33262941 · DOI 10.3389/fonc.2020.560487
5. Pharmacological targeting of the cancer epigenome.
   Mabe NW, Perry JA, Malone CF, Stegmaier K. · · 2024 · cited 36× · PMID 38937652 · DOI 10.1038/s43018-024-00777-2
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
7. New synergistic combination therapy approaches with HDAC inhibitor quisinostat, cisplatin or PARP inhibitor talazoparib for urothelial carcinoma.
   Meneceur S, De Vos CE, Petzsch P, Köhrer K, et al · · 2024 · cited 7× · PMID 38693852 · DOI 10.1111/jcmm.18342
8. Immunosenescence: Molecular Mechanisms, Diseases, and Therapeutic Innovations.
   Gong N, Pan X, Deng Y, Che J, et al · · 2025 · cited 4× · PMID 41427020 · DOI 10.1002/mco2.70515