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.

Pfizer

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Dexamethasone

Drug: PD 0332991

Drug: Bortezomib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00555906

A5481004

2010-022515-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC).
Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 previous treatments and with a life expectancy of more than 3 months.
Phase 2: Measurable (as defined by IMWGURC) disease after at least 1 previous treatment.

Exclusion criteria

History of allogeneic stem cell transplant.
Phase 2 only: Prior bortezomib therapy will only be allowed if there was a demonstrated positive response, and disease progression occurred off therapy.
Must have not experienced significant blood level changes, e.g. very low platelets, while on previous bortezomib therapy
Prior radiation therapy to > 25% of the bone marrow (whole pelvis is 25%).