Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01183949|
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: AT7519M Drug: Bortezomib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Open-label Multicenter Study of AT7519M Alone and in Combination With Bortezomib in Patients With Previously Treated Multiple Myeloma|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||March 2015|
Patients will be enrolled into 3 groups which will run sequentially. Groups A and B will receive AT7519M only, whereas Group C will receive AT7519M in combination with Bortezomib.
Part A: Nine patients will receive AT7519M as an intravenous infusion on days 1, 4, 8 and 11 of a three week cycle. The starting dose of AT7519M will be 21mg/m^2/dose and will be increased to 27mg/m^2/dose during subsequent cycles in the absence of AT7519M-related toxicities.
Part B: Amendment clarified there will be no further exploration of AT7519M as a monotherapy.
Part C: Amendment modified dose escalation to a conventional 3 + 3 design with a maximum total of 14 patients will be treated at the maximum tolerated dose.
Part C will treat between 3-26 patients with a combination of bortezomib and AT7519M in a dose escalation design. The starting doses for the dose escalation are bortezomib 1 mg/m2 and AT7519M 14 mg/m2.
- To evaluate the clinical efficacy of AT7519M alone or in combination with bortezomib [ Time Frame: Subjects with be followed until disease progression (an average of 4 cycles per subject. i.e an average of 84 days) ]Efficacy will be assessed using the International Multiple Myeloma Working Group (IMWG) Response Criteria
- Assess the type, incidence and severity of clinically significant treatment emergent adverse events as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) V 4.03 [ Time Frame: Subjects with be followed until disease progression (an average of 4 cycles per subject, i.e an average of approximately 84 days) ]
- To define the pharmacokinetic profile of AT7519M and bortezomib when administered alone or in combination with bortezomib [ Time Frame: 2 cycles (i.e an average of 42 days) ]The pharmacokinetic evaluation will include the calculation of plasma clearance and elimination phase half-life for AT7519M and bortezomib
- To identify the maximum tolerated dose (MTD) of AT7519M in combination with bortezomib [ Time Frame: Subjects with be followed until disease progression (an average of 4 cycles per subject, i.e an average of approximately 84 days) ]The MTD will be based on the incidence of dose limiting toxicities
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): NCT01183949
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, MA02115|
|Dana Faber Cancer Institute|
|Boston, Massachusetts, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Centre|
|New York, New York, United States, 10065|
|United States, Wisconsin|
|MCW and Froedtert Clinical Cancer Center, Division of Neoplastic Diseases & Related Disorders|
|Milwaukee, Wisconsin, United States, 53226|