A Study of JNS002 (Doxorubicin Hydrochloride Liposome Injection) in Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01371227|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : July 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: JNS002||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 of JNS002 (Doxorubicin HCl Liposome Injection) in Combination With Bortezomib for Japanese Patients With Relapsed or Refractory Multiple Myeloma|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
JNS002 30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.
30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 21 days ]
- Number of subjects who achieved a complete response or partial response [ Time Frame: Up to 126 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371227
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|