Clinical trial NCT00664898: A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: anti-CD40
Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Seagen Inc.
First posted: 2008-04-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
timeFrame: Length of study
Secondary outcomes:
measure: Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib
timeFrame: Length of study
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Sandra Skettino, M.D.
role: STUDY_DIRECTOR
References: