An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

Phase 2 Completed 53 enrolled Pfizer

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® \[bortezomib\] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.

Timeline

Start: 2008-01
Primary completion: 2012-08
Completion: 2013-03

Publications

Niesvizky R, Badros AZ, Costa LJ, Ely SA, Singhal SB, Stadtmauer EA, Haideri NA, Yacoub A, Hess G, Lentzsch S, Spicka I, Chanan-Khan AA, Raab MS, Tarantolo S, Vij R, Zonder JA, Huang X, Jayabalan D, Di Liberto M, Huang X, Jiang Y, Kim ST, Randolph S, Chen-Kiang S. Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. Leuk Lymphoma. 2015;56(12):3320-8. doi: 10.3109/10428194.2015.1030641. Epub 2015 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	0.7 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1.3 mg/m2	Intravenous
Subject	Palbociclib	Small molecule	50 mg	Oral
Subject	Palbociclib	Small molecule	75 mg	Oral
Subject	Palbociclib	Small molecule	100 mg	Oral
Subject	Palbociclib	Small molecule	125 mg	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

Summary

Timeline

Publications

Drugs

Indications