Clinical trial NCT00525447: Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma
Official title: A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-09-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events and lab abnormalities.
timeFrame: Within 3 weeks of final infusion of SGN-40
Secondary outcomes:
measure: Best clinical response, progression-free survival, and overall survival.
timeFrame: Study duration
measure: PK profile.
timeFrame: Within 3 weeks of final infusion of SGN-40
measure: Anti-drug antibody immune responses.
timeFrame: Within 3 weeks of final infusion of SGN-40
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Seagen Inc.
name: Nancy Whiting, PharmD
role: STUDY_DIRECTOR
References: