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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664898
• Other study ID #: ACF4375g
• Status: Completed
• Phase: Phase 1
• Start date: May 2008
• Est. completion date: April 8, 2010

Study information

• Verified date: December 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 8, 2010
• Est. primary completion date: April 8, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• bortezomib
Escalating intravenous repeating dose
• SGN-40
Escalating intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Seagen Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose of SGN-40 when combined with bortezomib		Length of study
Secondary	Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib		Length of study