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A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664898
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : November 15, 2011
Seagen Inc.
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is an open-label, multicenter, Phase Ib study to be conducted at approximately eight sites in Europe and the U.S. designed to evaluate the safety, pharmacokinetics, and activity of SGN-40 when combined with bortezomib in patients with multiple myeloma that is relapsed or refractory after at least one prior systemic treatment regimen.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: bortezomib Drug: SGN-40 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase Ib, Dose-Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination With Bortezomib (Velcade®, PS-341) in Patients With Relapsed or Refractory Multiple Myeloma
Study Start Date : May 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: 1 Drug: bortezomib
Escalating intravenous repeating dose

Drug: SGN-40
Escalating intravenous repeating dose

Primary Outcome Measures :
  1. Determine the maximum tolerated dose of SGN-40 when combined with bortezomib [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years
  • Documented pathologic diagnosis of multiple myeloma that has relapsed or failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
  • Measurable disease
  • At least one prior systemic therapy other than single-agent corticosteroids
  • European Union patients must have had prior bone marrow transplant (autologous) or be ineligible for transplant
  • If previously received bortezomib, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥ 6 months from the start of that therapy
  • If previously received bortezomib, must have recovered from bortezomib-related toxicities and must have a peripheral neuropathy score of Grade ≤ 1, according to the NCI CTCAE v3.0
  • If applicable, completion of autologous transplant ≥ 12 weeks prior to Day 1
  • Discontinuation of previous anticancer or investigational therapy for ≥ 21 days prior to treatment, or ≥ 90 days prior to treatment for previous monoclonal antibody administration

Exclusion Criteria:

  • Prior allogeneic bone marrow transplant
  • Other invasive malignancies within 3 years prior to Day 1 except for adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, breast, or prostate; or other cancer of which the patient has been disease-free for ≥ 3 years
  • Prior anaphylactic reaction to human immunoglobulin administration
  • Symptomatic hyperviscosity syndrome
  • Active infection requiring parenteral antibiotics within 14 days of Day 1
  • Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
  • Clinically significant cardiac dysfunction or other significant organ dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664898

Sponsors and Collaborators
Genentech, Inc.
Seagen Inc.
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Study Director: Sandra Skettino, M.D. Genentech, Inc.
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Responsible Party: Genentech, Inc. Identifier: NCT00664898    
Other Study ID Numbers: ACF4375g
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011
Keywords provided by Genentech, Inc.:
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents