NCT02921893

Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome

Completed EARLY_PHASE1 Last updated 12 February 2025

What this trial tests

EARLY_PHASE1 trial testing Dexamethasone in Plasmacytoma in 21 participants. Completed in 13 May 2024.

Timeline

31 October 2016

Primary endpoint
21 April 2022

13 May 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	31 October 2016
Primary completion	21 April 2022
Estimated completion	13 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• Ixazomib Citrate — full drug profile →
• Lenalidomide — full drug profile →
• Questionnaire Administration

Conditions studied

• Plasmacytoma — all drugs for Plasmacytoma →
• POEMS Syndrome — all drugs for POEMS Syndrome →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Plasmacytoma or POEMS Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.

Publications & conference data

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

1. Neuroinflammation as a Factor of Neurodegenerative Disease: Thalidomide Analogs as Treatments.
   Jung YJ, Tweedie D, Scerba MT, Greig NH. · · 2019 · cited 116× · PMID 31867326 · DOI 10.3389/fcell.2019.00313
2. Comprehensive Diagnosis and Management of POEMS Syndrome.
   D'Sa S, Khwaja J, Keddie S, Keh RY, et al · · 2022 · cited 14× · PMID 36340912 · DOI 10.1097/hs9.0000000000000796
3. Recent Advances in the Treatment and Supportive Care of POEMS Syndrome.
   Bou Zerdan M, George TI, Bunting ST, Chaulagain CP. · · 2022 · cited 8× · PMID 36498588 · DOI 10.3390/jcm11237011
4. Mass cytometry identifies expansion of double positive and exhausted T cell subsets in the tumour microenvironment of patients with POEMS syndrome.
   Kourelis TV, Jevremovic D, Jessen E, Dasari S, et al · · 2020 · cited 4× · PMID 32080834 · DOI 10.1111/bjh.16522
5. Combined Therapy with Ixazomib, Lenalidomide, and Dexamethasone for Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy, and Skin Changes Syndrome.
   Suichi T, Misawa S, Sekiguchi Y, Shibuya K, et al · · 2022 · cited 1× · PMID 36047093 · DOI 10.2169/internalmedicine.8786-21