Clinical trial · Interventional
Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
NCT01553357CI-TRIAL-00006472completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Plasma Cell Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide, dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Overall response rate
- timeFrame
- 4 months
- description
- IMWG criteria
- measure
- Complete remission rate
- timeFrame
- 4 months
- description
- IMWG
- measure
- At least Very good partial remission rate
- timeFrame
- 4 months
- description
- IMWG
Secondary outcomes (4)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL * Age \> 18 years * ECOG performance status of 0,1 or 2 * Life expectancy of at least 12 weeks Exclusion Criteria: * Myocardial infarction within 6 months prior to enrollment or uncontrolled angina * Severe uncontrolled ventricular arrhythmias * ECG evidence of acute ischemia or active conduction system abnormalities * Female subjects either pregnant or breast-feeding * Serious medical or psychiatric illness * Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy) * History of severe hepatic dysfunction * Active infections or HIV positivity * Uncontrolled insulin-dependent diabetes mellitus * Uncompensated major thyroid or adrenal dysfunction * Hemodialysis or peritoneal dialysis * Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator) * ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
References
Publications (0)
Data not yet available
No reference posted for this study.