A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma

Summary

The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance. * Ixazomib capsules, given with dexamethasone tablets * Pomalidomide capsules, given with dexamethasone tablets All participants will take their study medicine on specific days during a 28-day cycle. The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home. After treatment, participants will visit the clinic every 12 weeks for a check-up. If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.

Timeline

Start

2017-08-01

Primary completion

2020-08-01

Completion

2021-11-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Pomalidomide 4 mg + Dexamethasone 40 mg vs Ixazomib 4 mg + Dexamethasone 20 mg; p =0.477; Hazard Ratio (HR) 0.847 (95% CI 0.535 to 1.341); Log Rank NCT03170882 ↗

paper there was no statistically significant difference between arms. PMID 35075109 ↗

Publications

• Dimopoulos MA, Schjesvold F, Doronin V, Vinogradova O, Quach H, Leleu X, Montes YG, Ramasamy K, Pompa A, Levin MD, Lee C, Mellqvist UH, Fenk R, Demarquette H, Sati H, Vorog A, Labotka R, Du J, Darif M, Kumar S. Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial. Blood Cancer J. 2022 Jan 24;12(1):9. doi: 10.1038/s41408-021-00593-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixazomib	Unknown	5.5 mg	Oral
Comparator	Pomalidomide	Other / unclassified	4 mg	Oral
Background	Dexamethasone	Small molecule	10 mg	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral

Indications