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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-02-28

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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

SGN-40

Intervention Type DRUG

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.

lenalidomide

Intervention Type DRUG

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

dexamethasone

Intervention Type DRUG

40 mg administered weekly.

Interventions

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SGN-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.

Intervention Type DRUG

lenalidomide

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

Intervention Type DRUG

dexamethasone

40 mg administered weekly.

Intervention Type DRUG

Other Intervention Names

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dacetuzumab Revlimid Decadron

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No