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Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma.

Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma. - Low-dose thalidomide treatment for patients with relapsed and refractory multiple myeloma.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000005960
Enrollment
70
Registered
2011-07-11
Start date
2013-03-01
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

multiple myeloma

Interventions

None listed

Sponsors

Gunma Hematological Disease Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) symptomatic myeloma according to the criteria ofIMWG. (2)Relapsed and refractory myeloma after at least 1 treatment regimen. (3)Patients who know they had multiple myeloma. (4)Patients who are planned to be treated with thalidomide. (5)Patients who had measurable M-protein.(IgG >= 1.0 g/dl, IgA, IgD >=0.5g/dl) or urin M-protein(>=0.2 g/day). (6)>=20 years-old (7)Patients with ECOG performance status:0-2 (Patients with PS 3 restricted by bone lesions are allowed to participate) (8)Patients who are mached the below; 1)neutrophil count>=1,000/mm3 2)platelet count >=5x104/mm3 3)AST <=X2.5 of upper limit 4)ALT <=X2.5 of upper limit 5)Total bilirubin <=X1.5 of upper limit 6)SaO2 >= 90%(room air) (9)No deep vein thrombosis or pulmonary embolism. (10)Patients who have given written informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with uncontrollable infection. (2)patients with psychological diseases. (3)female who can have children. (4)patients who the doctor think unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
incidence of adverse events and response rate

Secondary

MeasureTime frame
2-year progression free survival and 2-year overall survival

Countries

Japan

Contacts

Public ContactGunma Hematology Study Group

Gunma Graduate School of Health Scineces Gunma Graduate School of Health Scineces

+81-27-220-8973

Outcome results

None listed

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