Multiple MyelomaNCT01234129
Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Assess the impact in outcome of the use of zoledronic acid in multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- zoledronic acid
- How many people
- 320 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2002to Dec 2009
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple myeloma previously untreated
Who may be able to join
- Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -
Who cannot join
- Pregnancy HIV + Refuse treatment
- -
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Tertiary reference oncology center
Mexico City, Mexico City, 06725
About this study
Official title: Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma
Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.
Read the detailed description
Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.
- Conditions
- Multiple Myeloma
- Being tested
- zoledronic acid
- Keywords
- multiple myeloma, stem cell transplant, zoledronic acid
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years
| Study group | Role | What they receive |
|---|---|---|
| zoledronic acid or not zoledronic acid | patients with multiple myeloma will be treated with cytoreductive therapy following by zoledronic acid or not. Receives: Drug: zoledronic acid | |
| zoledronic acid or not zoledronic acid | patients with multiple myeloma will be treated with cytoreductive therapy following by stem cell transplant and did not received zoledronic acid Receives: Drug: zoledronic acid | |
| zoledronic acid | Patients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free disease and overall toxicity in myeloma multiple
In patients treated with cytoreductive therapy following by stem cell transplant and that received zoledronic acid by 2 years,they were evaluable for assess antitumor effect of zoledronic acid
Measured: 3 years
Secondary outcomes (1)
skeletal event
evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJun 2002
- Primary completionDec 2009
- Study completionDec 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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Investigators
- Agustin Aviles, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234129
- Sponsor's protocol ID
- kitty1
- Other IDs
- kitty2
- Status last verified
- Dec 2009
- First submitted
- 3 Nov 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01234129
- Acronym / sponsor ID
- kitty1
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, stem cell transplant, zoledronic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Jun 2002
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Nov 2010 (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.
Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.
Detailed description
Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zoledronic acid or not zoledronic acid | – | Drug: zoledronic acidpatients with multiple myeloma will be treated with cytoreductive therapy following by zoledronic acid or not. |
| zoledronic acid or not zoledronic acid | – | Drug: zoledronic acidpatients with multiple myeloma will be treated with cytoreductive therapy following by stem cell transplant and did not received zoledronic acid |
| zoledronic acid | – | Drug: zoledronic acidPatients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma previously untreated
Key inclusion criteria (1 listed)
- Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -
Key exclusion criteria (2 listed)
- Pregnancy HIV + Refuse treatment
- -
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 |
|---|---|---|
| zoledronic acidzoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years | Drug | zoledronic acid, zoledronic acid or not zoledronic acid |
Primary outcome
progression-free disease and overall toxicity in myeloma multiple
Time frame: 3 years
In patients treated with cytoreductive therapy following by stem cell transplant and that received zoledronic acid by 2 years,they were evaluable for assess antitumor effect of zoledronic acid
1 secondary outcome
skeletal event
Time frame: 3 years
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 4 Nov 2010.
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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.
Agustin Aviles, MD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 1 inclusion and 2 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 4 Nov 2010. 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 Mexico. 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.
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?
progression-free disease and overall toxicity in myeloma multiple (time frame: 3 years). 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 4 Nov 2010.