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the study of the influence of the harvest of the CD34 positive peripheral blood stem cell of the induction therapy using lenalidomide,cyclophosphamide,dexamethasone(RCd therapy) for untreated symptomatic multiple myeloma

the study of the influence of the harvest of the CD34 positive peripheral blood stem cell of the induction therapy using lenalidomide,cyclophosphamide,dexamethasone(RCd therapy) for untreated symptomatic multiple myeloma - the study of the influence of the harvest of peripheral blood stem cell using RCd therapy for multiple myeloma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008868
Enrollment
20
Registered
2012-09-07
Start date
2012-09-01
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

1) high dose dexamethasone therapy 1 cycle is 28 days (day1-4,7-10,17-20) 1 cycle is administered 2)RCd therapy Combination therapy of lenalidomide,cyclophosphamide and dexamethasone each cycle is

Sponsors

Kagoshima University Hospital, Dept. Hematology and Immunology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)symptomatic untreated multiple myeloma diagnosed by criteria of IMWG 2)Aged 20 to 65 years old 3)Performance Status(PS) of 0-2 on ECOG scale 4)The function of the organ is kept,and the following standards are filled 4-1 bone marrow function 4-1-1 the neutrophil counts is 1,000/micro liter or more 4-1-2 the platelet is 5,0000/micro liter or more 4-1-3 Hb is 8.0 g/dl or more 4-2 liver function 4-2-1 The serum AST,ALT value is less than twice a facilities standard value. 4-2-2 The serum total bilirubin value is 2.0 mg/dl or less 4-3 renal function 4-3-1 The serum creatinine value is 2.0 mg/dl or less 4-4 cardiac function 4-4-1 QTc prolongation,ischemic change,atrial fibrillation and ventricular arrhythmia to need treatment is neither found in echocardiography. 4-4-2 LV Ejection Fraction is 50 percent or more. 4-5 respiratory function 4-5-1 Abnormal findings in lung field are not recognized on X-ray

Exclusion criteria

Exclusion criteria: 1)myeloma of nonsecreted form, plasma cell leukemia 2)patients of HIV antibody positivity, HCV antibody positivity and HBs antigen positivity 3)patients who are defective to control liver , renal ,cardiac or respiratory function and patients who suffer from diabetes, high blood pressure and infectious disease. 4) patients who suffer from brisk double cancer 5)patients of serious mental disorder 6)pregnant women and possibility getting pregnant,and suckling during examination period 7)patients who admit lung injury according to clinical findings. And patients who recognize abnormal shadow in the lung field on the Xp or CT. 8)Additionally, patients whom doctor in charge judges inappropriate

Design outcomes

Primary

MeasureTime frame
the amount of autologus blood stem cell harvest

Secondary

MeasureTime frame
response rale

Countries

Japan

Contacts

Public ContactKawada Hideaki

Kagoshima University Hospital Dept Hematology and Immunology

hkawada@m.kufm.kagoshima-u.ac.jp099-275-5934

Outcome results

None listed

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