Multiple MyelomaPhase 1NCT00664898
A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing bortezomib and SGN-40 in people with Multiple Myeloma, run by Genentech, Inc..
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib and SGN-40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- May 2008to 8 Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- bortezomib, SGN-40
- Keywords
- anti-CD40, Myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Escalating intravenous repeating dose
SGN-40Drug
Escalating intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bortezomib; Drug: SGN-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
Measured: Length of study
Secondary outcomes (1)
Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMay 2008
- Primary completion8 Apr 2010
- Study completion8 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Sandra Skettino, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664898
- Sponsor's protocol ID
- ACF4375g
- Status last verified
- Dec 2022
- First submitted
- 21 Apr 2008
- Last updated
- 12 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00664898
- Acronym / sponsor ID
- ACF4375g
- Conditions
- Multiple Myeloma
- Keywords
- anti-CD40, Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Study start
- May 2008
- Primary completion
- 8 Apr 2010 (actual)
- Study completion
- 8 Apr 2010 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bortezomib, Drug: SGN-40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibEscalating intravenous repeating dose | Drug | 1 |
| SGN-40Escalating intravenous repeating dose | Drug | 1 |
Primary outcome
Determine the maximum tolerated dose of SGN-40 when combined with bortezomib
Time frame: Length of study
1 secondary outcome
Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib
Time frame: Length of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Skettino, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib and SGN-40 in people with Multiple Myeloma, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose of SGN-40 when combined with bortezomib (time frame: Length of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.