Multiple MyelomaPhase 2NCT00096837
A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Motexafin Gadolinium Injection in people with Multiple Myeloma, run by Pharmacyclics LLC. at 1 site in United States.
Trial summary
The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory 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?
- Motexafin Gadolinium Injection
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- Relapsed or Refractory Multiple Myeloma
- ≥ 18 years old
- Able to provide consent for participation
- ECOG status 0-2
- Lab values:
- ANC ≥ 1,000/µL
Show all 14Show fewer
- WBC count ≥ 2.0/µL
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 50,000/µL
- AST and ALT ≤ 2 x ULN
- Total Bilirubin ≤ 2 x ULN
- Creatinine ≤ 2.0 mg/dL
- and
- Not pregnant or lactating
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
About this study
Official title: An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Motexafin Gadolinium Injection
- Keywords
- Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple 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.
Motexafin Gadolinium InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete response, partial response and stable disease (clinical benefit rate)
Secondary outcomes (2)
Progression-free survival
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2004 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096837
- Sponsor's protocol ID
- PCYC-0215
- Status last verified
- Jun 2006
- First submitted
- 16 Nov 2004
- Last updated
- 8 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00096837
- Acronym / sponsor ID
- PCYC-0215
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- First posted
- 17 Nov 2004 (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 the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Relapsed or Refractory Multiple Myeloma
- ≥ 18 years old
- Able to provide consent for participation
- ECOG status 0-2
- ANC ≥ 1,000/µL
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motexafin Gadolinium Injection | Drug | – |
Primary outcome
Rate of complete response, partial response and stable disease (clinical benefit rate)
2 secondary outcomes
Progression-free survival
Safety and tolerability
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 8 Jun 2006.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motexafin Gadolinium Injection in people with Multiple Myeloma, run by Pharmacyclics LLC. at 1 site 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 14 inclusion and 0 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 8 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Rate of complete response, partial response and stable disease (clinical benefit rate). 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 8 Jun 2006.