Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02315157|
Recruitment Status : Withdrawn (Withdrawn by PI)
First Posted : December 11, 2014
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Plasma Cell Leukemia||Drug: Bendamustine||Phase 1|
I. To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma.
I. To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma.
II. To describe the response after bendamustine
OUTLINE: This is a dose-escalation study.
Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma|
|Estimated Primary Completion Date :||January 2020|
Experimental: Bendamustine 200 mg/m2
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).
Experimental: Bendamustine 250 mg/m2
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).
- Maximum tolerated dose of bendamustine [ Time Frame: 2 days ]Defined as the dose where no more than 1 out of 6 patients experience dose-limiting toxicities. Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Incidence of toxicity (NCI CTCAE version 4.0) [ Time Frame: Up to 92 days following the last administration of study treatment ]Graded according to NCI CTCAE version 4.0
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): NCT02315157
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Manish Sharma, MD||Thomas Jefferson University|