Phase 2
Completed N=11
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
Source: ClinicalTrials.gov NCT00812968 ↗Enrolled (actual)
11
Serious AEs
27.3%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AE) — 11; 11; 11; 11 participants
Summary
The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body [pharmacokinetics]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) |
11; 11; 11; 11; 3; 1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Lenalidomide |
136; 149 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Lenalidomide |
2.52; 2.93 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide |
718.4; 803.5 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide |
866.5; 877.9 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide |
878.0 | — |
| SECONDARY Terminal Half-life (T1/2) of Lenalidomide |
3.26; 3.57 | — |
| SECONDARY Apparent Volume of Distribution (VzF) of Lenalidomide |
53.6; 58.6 | — |
| SECONDARY Apparent Total Plasma Clearance (CL/F) of Lenalidomide |
189.8; 189.9 | — |
| SECONDARY Apparent Terminal Elimination Rate Constant of Lenalidomide |
0.213; 0.194 | — |
| SECONDARY Number of Participants With a Erythroid Response |
11; 11 | — |
| SECONDARY Time to Erythroid Response |
2.1; 6.3 | — |
| SECONDARY Duration of Erythroid Response |
76.6; 72.1 | — |
| SECONDARY Change From Baseline in Hemoglobin Concentration |
7.0; 13.1; 6.0 | — |
| SECONDARY Number of Participants With a Neutrophil Response |
1; 0 | — |
| SECONDARY Number of Participants With a Platelet Response |
— | — |
| SECONDARY Number of Participants With a Cytogenetic Response |
1; 5 | — |
| SECONDARY Change From Baseline in Percentage of Bone Marrow Erythroblasts |
36.5; 21.5 | — |
| SECONDARY Percentage of Bone Marrow Myeloblasts |
3.77; 1.47; 1.79 | — |
| SECONDARY Percentage of Bone Marrow Promyelocytes |
5; 5; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 20 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality
- Symptomatic anemia secondary to MDS defined as:Untransfused Hb level 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3.0 x Upper Limit of Normal (ULN)
Data sourced from ClinicalTrials.gov (NCT00812968). 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.