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

NCT ID: NCT00664898

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-04-08

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.

Conditions

Multiple Myeloma

Keywords

anti-CD40; Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

Escalating intravenous repeating dose

SGN-40

Intervention Type: DRUG

Escalating intravenous repeating dose

Interventions

bortezomib

Escalating intravenous repeating dose

Intervention Type: DRUG

SGN-40

Escalating intravenous repeating dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Skettino, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

France; Netherlands; Spain; United States

Other Identifiers

ACF4375g

Identifier Type: -

Identifier Source: org_study_id