Phase 2
Completed N=21
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.
Source: ClinicalTrials.gov NCT00555906 ↗Enrolled (actual)
21
Serious AEs
35.3%
Results posted
Mar 2015
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1 — NA; 100 milligram (mg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1 |
NA; 100 | — |
| PRIMARY Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1 |
NA; 100 | — |
| PRIMARY Percentage of Participants With Objective Response (OR): Phase 2 |
20 | — |
| SECONDARY Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1 |
— | — |
| SECONDARY Best Overall Response: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Tumor Progression (TTP): Phase 2 |
3.9 | — |
| SECONDARY Progression-free Survival (PFS): Phase 2 |
3.9 | — |
| SECONDARY Duration of Objective Response (DR): Phase 2 |
4.63 | — |
| SECONDARY Overall Survival (OS): Phase 2 |
21.1 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) by Severity: Phase 2 |
2; 9; 18; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2 |
30; 27 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Phase 2 |
30 | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2 |
60.80; 64.20; 59.88; 70.37; 72.22; 69.14 | — |
| SECONDARY Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2 |
35.68; 25.61; 46.50; 24.69; 35.51; 23.90 | — |
| SECONDARY Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2 |
2.32; 2.62; 2.44; 2.30; 2.12; 2.02 | — |
Eligibility 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%).
Data sourced from ClinicalTrials.gov (NCT00555906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.