臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 18, 2019
Last modified on	Mar. 26, 2021
Trial ID	jRCTs031180336

Scientific Title	Phase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for multiple myeloma
Public Title	LDCY-MM study

Contact for Scientific Queries	Name	Sakaida Emiko
	Affiliation	Department of Hematology, Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba
	Telephone	+81-43-222-7171
	E-mail	esakaida@faculty.chiba-u.jp
Contact for Public Queries	Name	Mitsukawa Shio
	Affiliation	Department of Hematology, Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba
	Telephone	+81-43-222-7171
	E-mail	shio-sakai@chiba-u.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 01, 2015
Actual date of first enrollment		Sept. 02, 2015
Target sample size		22
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients diagnosed with multiple myeloma based on IWMG criteria 2) Bone marrow plasma cells under 5% after chemotherapy 3) Lenalidomide treatment under 4 cycles 4) More than 4 weeks after the beginning day of the last chemotherapy 5) Age 20-70 6) ECOG PS 0-2 7) Within 14 days prior to registration Neutrophil over 1,000/mm3 Hemoglobin over 8.0g/dl Platelet over 100,000/mm3 GOT, GPT under 2.5 times the upper limit of normal level Total bilirubin under 2.0mg/dl Creatinine under 2.0mg/dl ECG WNL or trivial change without any symptoms SpO2 over 95% 8) More than 3 months survival expected 9) Informed consent obtained
	Exclusion Criteria	1) Pregnant or lactating females. Patients who cannot do contraception. 2) Complications of active other cancers. 3) Severe psychological disorder 4) HBsAg positive or HBV-DNA positive. 5) HIV-Ab positive. 6) Plasma cells in the peripheral blood. 7) Severe drug allergy. 8) Active infection. 9) Any other problems regarded as disqualification by doctors.
	Age Minimum	20age old over
	Age Maximum	70age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Multiple myeloma
Intervention(s)		Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)
Health Condition(s) Keyword		Multiple myeloma
Intervention(s) Keyword		PBSCH, cyclophosphamide, lenograstim
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Success rate of PBSCH to obtain 2 times10^6/kg CD34 positive cells for a transplantation
Secondary Outcome(s)		effectiveness Day of engraftment safety Frequency of adverse events (any grade/grade 3 and more), frequency of adverse response against drugs

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Mar. 26, 2021	(this page)	Changes
3	June. 10, 2020	Detail	Changes
2	April. 30, 2020	Detail	Changes
1	Mar. 18, 2019	Detail

List of change history