Overview

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.

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with VelcadeĀ® [bortezomib] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Palbociclib
Criteria
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%).