Recapturing Disease Response: A Phase II Study of High Dose Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma Who Have Progressed on Standard Dose Carfilzomib
This is an open label, single center, phase II study of high dose carfilzomib. Patients with
relapsed or relapsed/refractory myeloma and with progression of disease on standard dosing
(20/27 mg/m2) and schedule of carfilzomib will be initially treated at dose level 1,
carfilzomib 20/56 mg/m2. During Cycle 1, patients will receive either 20 mg/m2 on days 1,2
(if the subject has not received carfilzomib as part another clinical trial within the last
4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of
disease on carfilzomib within the last month - for example subjects enrolled in CMAP
compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the
remaining doses given Cycle 1 Day 8 onwards. If a minimal response or better is achieved
(and therefore disease response is recaptured) a bone marrow biopsy will be repeated.
If 56 mg/m2 is not tolerated, the dose of carfilzomib will be reduced to dose level -1 i.e.
45 mg/m2. If a subject does not tolerate 45 mg/m2 then the dose would be further reduced to
dose level -2 i.e. 36 mg/m2. If the subject does not tolerate 36 mg/m2, then this subject
would have to come off study.
Dexamethasone 8 mg po/IV will be administered prior to all carfilzomib doses.
Once a patient develops disease progression on this study, the patient may return to
receiving the maximum tolerated dose of carfilzomib by that patient with the addition of a
therapeutic dosing of dexamethasone (a total of 20-40 mg weekly). An IMId (e.g. thalidomide
or lenalidomide) and/or an alkylator can also be added to carfilzomib 27 or 36 mg/m2 per
investigator discretion either concurrent with the addition of dexamethasone or subsequent
to disease progression on carfilzomib with concurrent therapeutic dexamethasone.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Efficacy of High Dose Carfilzomib
To explore the safety and efficacy of high dose carfilzomib who developed disease progression on the standard dosing and schedule of carfilzomib
up to 4 years
Yes
Ajai Chari, MD
Principal Investigator
Mount Sinai School of Medicine
United States: Food and Drug Administration
GCO 12-1506
NCT01775553
February 2013
August 2016
Name | Location |
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Mount Sinai Medical Center | New York, New York 10029 |