Elucidation of efficacy, safety, mutations, and immunologic factors in ixazomib maintenance therapy for transplant-ineligible patients with multiple myeloma intolerant to lenalidomide therapy due to frailty or adverse events

Elucidation of DNA mutation dynamics and identification of the immunologic factors affecting the efficiency in ixazomib maintenance therapy for multiple myeloma patients intolerant to lenalidomide maintenance therapy due to frailty or adverse events - Ixazomib-maintenance therapy for transplant-ineligible patients intolerant to lenalidomide: IMTIL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048285

Enrollment

Registered

2022-07-14

Start date

2022-07-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primary entry 1)Transplant-ineligible multiple myeloma patients. 2)Intolerant to 25mg dose of lenalidomide. 3)Those plan to start maintenance therapy with ixazomib. 4)Those can give a written consent to participate in this research. Secondary entry 1)Those completed primary entry and gained effectiveness such as PR and better after induction therapy. 2)Lenalidomide-intolerant patients who gained effectiveness such as PR and better after induction therapy. 3)Those plan to start maintenance therapy with ixazomib for two years.

Exclusion criteria

Exclusion criteria: Primary entry 1)Those have a past history of allergy to ixazomib 2)Pregnant woman or possible pregnant woman Secondary entry 1)Those were treated by 25mg dose of lenalidomide as an induction therapy

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
(1)Identification of driver mutations using whole-genome sequencing (WGS) and quantification of the size of clones with driver mutations in BM using digital droplet polymerase chain reaction (PCR). (2)Examination of the dynamics of IgG, IgA, IgM as well as flow cytometric analysis of immune related genes in myeloma and effector cells. (3)Time to Next Treatment (TTNT).	—

Countries

Japan

Contacts

Public ContactYoichi Imai

Dokkyo Medical University Department of Hematology and Oncology

imaiyo-tky@umin.ac.jp0282-86-1111

Outcome results