Multiple MyelomaPhase 1NCT00231166
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
A Phase 1 study testing HCD122 in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- HCD122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2005to May 2009
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of MM requiring treatment
- Refractory or Relapsed Disease
- At least one prior treatment regimen
- Male or Female
- >18 years of age
Who cannot join
- Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
- Intracranial disease or epidural disease
- Clinically significant cardiac dysfunction or other significant organ dysfunction
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102
Boston, Massachusetts, 02115
St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer
New York, New York, 10011
University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102
Philadelphia, Pennsylvania, 19104
Oregon Health Sciences University
Portland, Oregon, 97239
Fred Hutchinson Cancer Research Center Dept. of FHCRC
Seattle, Washington, 98109
Australia2 sites
Novartis Investigative Site
Herston, Queensland, 4029
Novartis Investigative Site
Prahran, Victoria, 3181
About this study
Official title: A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101)
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
- Conditions
- Multiple Myeloma
- Being tested
- HCD122
- Keywords
- dose-finding, monoclonal antibody, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCD122Drug
| Study group | Role | What they receive |
|---|---|---|
| HCD122 | Experimental | Not described Receives: Drug: HCD122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, pharmacokinetics and pharmacodynamics at multiple doses
Measured: At the completion of each dose escalation cohort
Secondary outcomes (1)
Clinical response after various doses
Measured: Once a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2009
- Study completionMay 2009
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 Novartis PharmaceuticalsThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231166
- Sponsor's protocol ID
- CHCD122A2102
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2005
- Last updated
- 11 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101)
- ClinicalTrials.gov ID
- NCT00231166
- Acronym / sponsor ID
- CHCD122A2102
- Conditions
- Multiple Myeloma
- Keywords
- dose-finding, monoclonal antibody, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Oct 2005 (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.
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCD122 | Experimental | Drug: HCD122 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical Diagnosis of MM requiring treatment
- Refractory or Relapsed Disease
- At least one prior treatment regimen
- Male or Female
- >18 years of age
Key exclusion criteria (3 listed)
- Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
- Intracranial disease or epidural disease
- Clinically significant cardiac dysfunction or other significant organ dysfunction
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 |
|---|---|---|
| HCD122 | Drug | HCD122 |
Primary outcome
Safety, pharmacokinetics and pharmacodynamics at multiple doses
Time frame: At the completion of each dose escalation cohort
1 secondary outcome
Clinical response after various doses
Time frame: Once a month
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 11 Oct 2018.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCD122 in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 7 sites in 2 countries.
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 5 inclusion and 3 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Safety, pharmacokinetics and pharmacodynamics at multiple doses (time frame: At the completion of each dose escalation cohort). 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 11 Oct 2018.