Multiple MyelomaPhase 1NCT00036140
Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
A Phase 1 study testing Investigational drug in people with Multiple Myeloma, run by Pfizer at 5 sites in United States.
Trial summary
The primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma. 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?
- Investigational drug
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Eligible patients must be at least 18 years of age with a diagnosis of multiple myeloma including elevated M-blood/urine protein or a tumor that can be evaluated by the doctor during the investigational drug's treatment.
- The patient's multiple myeloma must have gotten worse during/after previous chemotherapy was given.
- Any side-effects from prior chemotherapy must have subsided
- Blood and urine tests must show adequate bone marrow, liver, and kidney function.
Who cannot join
- Any of the following will exclude patients from study participation:
- indolent or smoldering myeloma or localized plasmacytoma
- hyperviscosity syndrome
- irradiation to 25% or more of bone marrow
- prior high dose chemotherapy with bone marrow or stem cell support
- current participation in other clinical trials
Show all 9Show fewer
- pregnant or breast-feeding women
- known HIV-positive or AIDS-related illness
- patients planning to have radiation therapy or surgery that would interrupt study therapy in the next 6 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Center
Cleveland, Ohio, 44106
Research Center
Los Angeles, California, 90033
Research Center
Los Angeles, California, 90048
Research Center
Marshfield, Wisconsin, 54449
Research Center
Rancho Mirage, California, 92270
About this study
The primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Investigational drug
- Keywords
- Pharmacia
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational drugDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
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 PfizerThe 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
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036140
- Sponsor's protocol ID
- 196-ONC-0100-006
- Status last verified
- Mar 2004
- First submitted
- 8 May 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00036140
- Acronym / sponsor ID
- 196-ONC-0100-006
- Conditions
- Multiple Myeloma
- Keywords
- Pharmacia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 9 May 2002 (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 primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible patients must be at least 18 years of age with a diagnosis of multiple myeloma including elevated M-blood/urine protein or a tumor that can be evaluated by the doctor during the investigational drug's treatment.
- The patient's multiple myeloma must have gotten worse during/after previous chemotherapy was given.
- Any side-effects from prior chemotherapy must have subsided
- Blood and urine tests must show adequate bone marrow, liver, and kidney function.
Key exclusion criteria (9 listed)
- indolent or smoldering myeloma or localized plasmacytoma
- hyperviscosity syndrome
- irradiation to 25% or more of bone marrow
- prior high dose chemotherapy with bone marrow or stem cell support
- current participation in other clinical trials
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 |
|---|---|---|
| Investigational drug | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational drug in people with Multiple Myeloma, run by Pfizer at 5 sites in United States.
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 4 inclusion and 9 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
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 24 Jun 2005.