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

NCT00525447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-10-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

lenalidomide

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

DRUG

dexamethasone

40 mg administered weekly.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Nancy Whiting, PharmD · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-01-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525447 on ClinicalTrials.gov