Clinical trial · Interventional
Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma
A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)
NCT00525447CI-TRIAL-00015811completedPhase 1ClinicalTrials.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 a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
| SGN-40 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: SGN-40
- Drug: lenalidomide
- Drug: dexamethasone
Primary outcomes (1)
- measure
- Adverse events and lab abnormalities.
- timeFrame
- Within 3 weeks of final infusion of SGN-40
Secondary outcomes (3)
- measure
- Best clinical response, progression-free survival, and overall survival.
- timeFrame
- Study duration
- measure
- PK profile.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma. * Received at least one prior systemic therapy other than single-agent corticosteroids. * Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal. Exclusion Criteria: * Received an allogenic stem cell transplant. * Previous intolerance of lenalidomide or dexamethasone. * Primary invasive malignancy (other than multiple myeloma) within the last 3 years.
References
Publications (0)
Data not yet available
No reference posted for this study.