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

This study has been completed.
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00664898
First received: April 21, 2008
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: bortezomib
Drug: SGN-40
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Determine the maximum tolerated dose of SGN-40 when combined with bortezomib [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bortezomib
Escalating intravenous repeating dose
Drug: SGN-40
Escalating intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664898

Sponsors and Collaborators
Genentech, Inc.
Seattle Genetics, Inc.
Investigators
Study Director: Sandra Skettino, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00664898     History of Changes
Other Study ID Numbers: ACF4375g
Study First Received: April 21, 2008
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
anti-CD40
Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014