A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
bortezomib
SGN-40
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring anti-CD40, Myeloma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
Secondary Outcome Measures
Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib
Full Information
NCT ID
NCT00664898
First Posted
April 21, 2008
Last Updated
December 9, 2022
Sponsor
Genentech, Inc.
Collaborators
Seagen Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00664898
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 8, 2010 (Actual)
Study Completion Date
April 8, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Seagen Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
anti-CD40, Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Description
Escalating intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
SGN-40
Intervention Description
Escalating intravenous repeating dose
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib
Time Frame
Length of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Skettino, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
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