Unique ID issued by UMIN | UMIN000010346 |
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Receipt number | R000012082 |
Scientific Title | A phase 2 study of cyclophosphamide, lenalidomide and dexamethasone (CRD) for patients with relapsed/refractory multiple myeolma |
Date of disclosure of the study information | 2013/03/28 |
Last modified on | 2015/04/01 21:15:17 |
A phase 2 study of cyclophosphamide, lenalidomide and dexamethasone (CRD) for patients with relapsed/refractory multiple myeolma
A phase 2 study of CRD for patients with relapsed/refractory multiple myeolma
A phase 2 study of cyclophosphamide, lenalidomide and dexamethasone (CRD) for patients with relapsed/refractory multiple myeolma
A phase 2 study of CRD for patients with relapsed/refractory multiple myeolma
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy of CRD as salvage chemotherapy for patients with relapsed/refractory multiple myeloma
Efficacy
Confirmatory
Pragmatic
Phase II
Overall response rate after CRD regimen
Complete response rate after CRD regimen
Overall response rate after lenalidomide maintenance therapy
Complete response rate after lenalidomide maintenance therapy
Progression free survival duration
Overall survival duration
incidence of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
CRD
Cyclophosphamide 300 mg/m2 po (day1, 8, 15, 22)
Lenalidomide 25 mg/body po (day1-21)
Dexamethasone 40 mg/body po (day1, 8, 15, 22)
CRD regimen is repeated every 4 weeks for 9 cycles
Lenalidomide maintenance therapy
Lenalidomide 10 mg/body po (day1-21)
Lenalidomide maintenance therapy is repeated every 4 weeks. Lenalidomide is administered until disease progression.
20 | years-old | <= |
Not applicable |
Male and Female
1. PS (ECOG) 0-2
2. Prior regimens >=1
3. Existence of measurable disease
4. The hemoglobin level >= 7.0mg/dl
5. The neutrophil counts >= 1,000/mm3
6. The platelet counts >= 50,000/mm3
7. T-bil <= 2.0 times of a facilities standard value
8. AST and ALT <= 3.0 times of a facilities standard value
9. CCr >= 30ml/min
1. Non-secretory type multiple myeloma
2. Plasma cell leukemia
3. Ca >= 14mg/dl
4. Allergy to cyclophosphamide, lenalidomide, and dexamethasone
5. Plan for PBSCH
6. Active infection
7. Hemorrhagic diathesis, and coagulation disorder
8. Uncontrollable diabetes mellitus, hypertension, angina pectoris or congestive heart failure
9. HBV, HCV, and HIV infection
10. Impossibility to receive anti-coagulation agents
11. History of operation in 4 weeks
12. History of radiation therapy in 2 weeks
13. History of anti-cancer therapy, biological therapy, and immunological therapy
14. History of allogeneic transplant
15. Pregnancy
16. Doctor judged inadequate to enroll the study
35
1st name | |
Middle name | |
Last name | Kazuhito Suzuki |
The Jikei University School of Medicine
Devision of Clinical Oncology/ Hematology
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
03-3433-1111
kaz-suzuki@jikei.ac.jp
1st name | |
Middle name | |
Last name | Kazuhito Suzuki |
The Jikei University School of Medicine
Devision of Clinical Oncology/ Hematology
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
03-3433-1111
kaz-suzuki@jikei.ac.jp
The Jikei University School of Medicine
None
Self funding
the Jikei University Daisan Hospital
the Jikei University Kashiwa Hospital
NO
東京慈恵会医科大学附属病院(東京都)
2013 | Year | 03 | Month | 28 | Day |
Unpublished
Open public recruiting
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 28 | Day |
2015 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012082
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