A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone ā¦ (NCT05183139) | Clinical Trial Compass
WithdrawnPhase 4
A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma
Stopped: Business decision (no enrollment)
0Started 2022-06-30
Plain-language summary
The main aim is to show that long-term use of ixazomib can improve symptoms of multiple myeloma and provide an effective long-term alternative treatment.
Participants will take ixazomib orally (by mouth) with pomalidomide and dexamethasone or lenalidomide and dexamethasone in 28-day treatment cycles. Participants will be treated for a maximum of 39 cycles but may continue to receive ixazomib beyond 39 cycles if they are benefiting from it. A follow-up study visit will occur 30 days after the last dose of ixazomib. Participants will be monitored for up to 3 years.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Has a diagnosis of multiple myeloma (MM) using current IMWG diagnostic criteria, and are relapsed or refractory to 1 to 3 prior lines of therapy\*.
ā. Has a diagnosis of non-secretory disease as long as the participant has a marker of disease that can be followed serially and assessed for response.
ā. Has an Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status of 0, 1, or 2 at the time of enrollment.
Exclusion criteria
ā. Has Grade \>2 peripheral neuropathy (PN), or Grade 2 PN with pain on clinical examination.
ā. Has not adequately recovered from other non-neuropathy AEs related to prior therapy in the opinion of the investigator at the time of enrollment.
ā. Is pomalidomide refractory.
ā. Has primary light chain amyloidosis (AL). Those with MM and concurrent AL are allowed.
ā. Has known central nervous system involvement by MM.
. Has infection requiring systemic antibiotic therapy or other serious infection within 14 days before enrollment.
ā. Has ongoing or active systemic infection, active hepatitis B or C virus infection, or known positive status for human immunodeficiency virus.
ā. Has been diagnosed or treated for another malignancy within 2 years before enrollment or has previously been diagnosed with another malignancy and has any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.