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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00525447

Enrollment

Registered

2007-09-05

Start date

2007-08-31

Completion date

2010-02-28

Last updated

2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

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

Brief summary

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.

Interventions

DRUGSGN-40

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.

DRUGlenalidomide

Up to 25 mg daily of a 21-day cycle.

DRUGdexamethasone

40 mg administered weekly.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Adverse events and lab abnormalities.	Within 3 weeks of final infusion of SGN-40

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026