NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001210

Registered date:26/06/2008

Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRelapse/Refractory Multiple Myeloma
Date of first enrollment2008/05/01
Target sample size28
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Bortezomib 1.0 mg/m2 or 1.3 mg/m2 on Days 1, 4, 8, and 11, IV Doxorubicin 9 mg/m2 on Day 1 to 4 IV Dexamethasone 20 mg daily on Days 1 to 2, 4 to 5, 8 to 9, and 11 to 12, orally Each cycle consist of 21-day treatment.

Outcome(s)

Primary OutcomeSafety Complete remission rate
Secondary OutcomePR rate PFS Time to response OS

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1.Use of bortezomib in the previous treatment. 2.History of allergic reactions to compounds containing mannitol, bortezomib, or boron 3.Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol. 4.Active infection requiring treatment 5.Active hepatitis B or C. 6.Under treatment for a cancer other than multiple myeloma 7.Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function. 8.Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome. 9.Peripheral neuropathy> grade 2 10.Pregnant, lactation or potential

Related Information

Contact

public contact
Name Yasushi Takamatsu
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka Japan
Telephone 092-801-1011
E-mail yasushi@fukuoka-u.ac.jp
Affiliation Fukuoka University Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine
scientific contact
Name KazuoTamura
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka Japan
Telephone 092-801-1011
E-mail ktamura@fukuoka-u.ac.jp
Affiliation Fukuoka University Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine