Phase 2
N=134
A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00737529 ↗Enrolled (actual)
134
Serious AEs
52.2%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC) — 29.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC) |
29.9 | — |
| PRIMARY Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee |
16.64 | — |
| SECONDARY Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee |
9.0 | — |
| SECONDARY Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee |
24.43 | — |
| SECONDARY Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee |
4.01 | — |
| SECONDARY Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee |
5.46 | — |
| SECONDARY Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee |
3.75 | — |
| SECONDARY Time to Response (TTR) |
3.5 | — |
| SECONDARY Time to Complete Response (CR+CRu) According to the Independent Review Committee |
3.9 | — |
| SECONDARY Overall Survival (OS) |
19.50 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
132; 118; 106; 101; 57; 18 | — |
Summary
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven mantle cell lymphoma
- Patients must have documents relapsed, refractory or PD after treatment with bortezomib
- Must have measureable disease on cross sectional imaging by CT
- Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
- Willing to follow pregnancy precautions
Exclusion Criteria
- Any of the following laboratory abnormalities
- Absolute neutrophil count (ANC) 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
- Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
- Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min
- Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
- History of active central nervous system (CNS) lymphoma within the previous 3 months
- Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
- Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
- Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Data sourced from ClinicalTrials.gov (NCT00737529). 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.