Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: SGN-40
* Drug: lenalidomide
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SGN-40<br>* 2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.<br>* Other names: dacetuzumab;Drug: lenalidomide<br>* Up to 25 mg daily of a 21-day cycle.<br>* Other names: Revlimid;Drug: dexamethasone<br>* 40 mg administered weekly.<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and lab abnormalities. |  | Within 3 weeks of final infusion of SGN-40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best clinical response, progression-free survival, and overall survival. |  | Study duration | 
| PK profile. |  | Within 3 weeks of final infusion of SGN-40 | 
| Anti-drug antibody immune responses. |  | Within 3 weeks of final infusion of SGN-40 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Multiple Myeloma, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Hemostatic Disorders, Immunoproliferative Disorders, Lymphoproliferative Disorders, Paraproteinemias, Vascular Diseases, Antibody-Dependent Cell Cytotoxicity