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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010346
Receipt No. 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

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Basic information
Public title A phase 2 study of cyclophosphamide, lenalidomide and dexamethasone (CRD) for patients with relapsed/refractory multiple myeolma
Acronym A phase 2 study of CRD for patients with relapsed/refractory multiple myeolma
Scientific Title A phase 2 study of cyclophosphamide, lenalidomide and dexamethasone (CRD) for patients with relapsed/refractory multiple myeolma
Scientific Title:Acronym A phase 2 study of CRD for patients with relapsed/refractory multiple myeolma
Region
Japan

Condition
Condition Multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of CRD as salvage chemotherapy for patients with relapsed/refractory multiple myeloma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate after CRD regimen
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhito Suzuki
Organization The Jikei University School of Medicine
Division name Devision of Clinical Oncology/ Hematology
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email kaz-suzuki@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhito Suzuki
Organization The Jikei University School of Medicine
Division name Devision of Clinical Oncology/ Hematology
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email kaz-suzuki@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor the Jikei University Daisan Hospital
the Jikei University Kashiwa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 28 Day
Last modified on
2015 Year 04 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012082

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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