Phase II study of weekly irinotecan (CPT-11) for relapsed and/or refractory multiple myeloma

Phase II study of weekly irinotecan (CPT-11) for relapsed and/or refractory multiple myeloma - Phase II study of weekly CPT-11 for relapsed and/or refractory multiple myeloma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001213

Enrollment

Registered

2008-07-01

Start date

2008-07-01

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

relapsed and/or refractory multiple myeloma after treatment with bortezomib or thalidomide (lenalidomide) in addition to the prior treatment with melphalan

Interventions

Three times administration of weekly irinotecan(CPT-11) followed by 2-week rest is repeated every four weeks for up to 8 courses.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) symptomatic multiple myeloma based on the criteria proposed by International Myeloma Working Group (IMWG) 2) relapsed and/or refractory cases after treatment with bortezomib or thalidomide (lenalidomide) in addition to the prior treatment with melphalan 3) having measurable lesions such as (1) serum paraprotein of more than 1.0g/dl IgG or 0.5g/dl IgA/IgD, (2) Bence Jones protein of more than 0.2g/day, and (3) plasmacytoma with more than 2cm in long diameter 4) performance status: 0-2, or 3 due to osteolytic lesions alone 5) at least 22 days have passed after the prior therapy 6) WBC: more than 3000/mm3 or neutrophil: more than 1500/mm3, AST/ALT: no more than 2.5 x normal upper limit, creatinine: no more than 1.5mg/dl, PaO2 (room air): more than 70torr, normal ECG and ejection fraction: more than 50% 7) written informed consent by the patient

Exclusion criteria

Exclusion criteria: 1) prior treatment history with irinotecan 2) serious allergic history 3) severe infection 4) diarrheae: more than 5 times a day 5) paralytic or mechanical ileus 6) massive pleural effusion or ascites 7) interstitial pneumonia, pulmonary fibrosis 8) uncontrollable diabetes mellitus 9) patients treated with warfarin 10) pregnant woman 11) symptomatic intracranial metastasis or invasion 12) psychosis 13) synchronous or metachronous malignancy 14) HBs-Ag positive or HIV-Ab positive 15) patients treated with atazanavir 16) blood infusion or G-CSF administration within 7 days 17) cardiac or gastrointestinal amyloidosis 18) inadequate to be enrolled in the protocol study

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression free survival, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactShigeru Kusumoto

Nagoya City University Hospital Division of Hematology and Collagen Diseases

kusshan@rb3.so-net.ne.jp0528515511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026