Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)-a trial by the Asian Myeloma Network
Journal
Blood Cancer Journal
Journal Volume
9
Journal Issue
10
Date Issued
2019
Author(s)
Soekojo C.Y.
Kim K.
Chim C.-S.
Takezako N.
Asaoku H.
Kimura H.
Kosugi H.
Sakamoto J.
Gopalakrishnan S.K.
Nagarajan C.
Wei Y.
Moorakonda R.
Lee S.L.
Lee J.J.
Yoon S.-S.
Kim J.S.
Min C.K.
Lee J.-H.
Durie B.
Chng W.J.
Abstract
Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma. However, the data in Asian patients remain limited. We conducted a prospective phase two clinical trial in major cancer centers in Singapore, South Korea, Taiwan, Japan and Hong Kong to assess the efficacy and safety of pomalidomide and dexamethasone combination (PomDex) +/? cyclophosphamide in Asian patients with relapsed/refractory multiple myeloma who failed lenalidomide and bortezomib. Patients were treated with pomalidomide (4 mg daily for 21 days every 4 weeks) and dexamethasone (40 mg weekly). If there is less than a minimal response after three cycles of PomDex, cyclophosphamide 300 mg/m2 can be added (PomCyDex). A total of 136 patients were enrolled. The median PFS was 9 and 10.8 months for the PomDex and PomCyDex group, respectively. The median OS was 16.3 months. This regimen appears to be active across age groups and prior lines of treatment. This combination was overall well tolerated with grade 3 and 4 adverse events of mainly cytopenias. PomDex is highly active and well-tolerated in Asian patients. The addition of cyclophosphamide can improve the response and outcomes further in patients with suboptimal response to PomDex. ? 2019, The Author(s).
SDGs
Other Subjects
bortezomib; cyclophosphamide; dexamethasone; lenalidomide; pomalidomide; antineoplastic agent; cyclophosphamide; dexamethasone; pomalidomide; thalidomide; aged; anemia; anorexia; anxiety; Article; blurred vision; cancer center; cancer combination chemotherapy; cancer patient; cancer survival; clinical outcome; constipation; controlled study; coughing; diarrhea; dizziness; drug dose reduction; drug efficacy; drug safety; drug tolerability; dyspnea; edema; emotional disorder; fatigue; febrile neutropenia; female; fever; headache; heart failure; Hong Kong; human; hypercalcemia; hypernatremia; hypertension; hypocalcemia; hypokalemia; hypotension; insomnia; Japan; kidney dysfunction; liver function test; major clinical study; male; multicenter study; multiple cycle treatment; multiple myeloma; muscle spasm; muscle weakness; nausea; neuralgia; neutropenia; overall survival; pain; peripheral neuropathy; phase 2 clinical trial; pleura effusion; pneumonia; progression free survival; randomized controlled trial; rash; sepsis; side effect; Singapore; South Korea; survival rate; survival time; Taiwan; thrombocytopenia; treatment response; upper respiratory tract infection; urinary tract infection; vein thrombosis; vomiting; Asian continental ancestry group; clinical trial; disease free survival; drug effect; drug resistance; multiple myeloma; pathology; prospective study; tumor recurrence; Aged; Antineoplastic Combined Chemotherapy Protocols; Asian Continental Ancestry Group; Cyclophosphamide; Dexamethasone; Disease-Free Survival; Drug Resistance, Neoplasm; Female; Humans; Male; Multiple Myeloma; Neoplasm Recurrence, Local; Prospective Studies; Thalidomide
Publisher
Nature Publishing Group
Type
journal article