Multiple MyelomaPhase 1/2TMI-ASCTNCT00800059
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma
A Phase 1/2 study testing Total Marrow Irradiation in people with Multiple Myeloma, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Total Marrow Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Nov 2025
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment.
- Subject must have primary refractory or relapsed multiple myeloma.
- Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
- Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
- An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation.
- Subject must be of age more than 18 and less than 60 years.
- Subject must have an ECOG performance score of 0,1, or 2.
- Subject must have the ability to comply with the protocol visit schedule and other protocol requirements.
Who cannot join
- A subject meeting any of the following criteria is not eligible for participation in the study:
- Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM.
- Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
- Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
- Subjects who have previously received radiation treatments or other neoplastic disorders.
- Subjects with a history of non-compliance in other studies.
- Pregnant or lactating female subjects.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Harold Atkins, MD, hatkins@ohri.ca
Rajiv Samant, MD
About this study
Official title: A Dose Escalation Study of Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) for the Treatment of Relapsed or Refractory Multiple Myeloma (MM)
The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Further,the investigators hypothesize that this will result in an improvement in disease response and disease control for patients with multiple myeloma. This is a dose escalation study of TMI with the primary objective of determining the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Total Marrow Irradiation
- Keywords
- Relapse, Refractory
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Marrow IrradiationRadiation
Also called TMI
Total Marrow Irradiation delivered by chemotherapy delivered to cohorts of patients in a dose escalation. The initial cohort will receive 14 Gy. If tolerated subsequent cohorts will receive an additional 2 Gy until the maximum tolerated dose or 28 Gy is reached.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with TMI and autologous Stem Cell transplant Receives: Radiation: Total Marrow Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
Measured: 30 days from the time of aSCT
Secondary outcomes (4)
The frequency and timing of engraftment following TMI and aHSCT
Measured: within 30 days of aHSCT
The early morbidity and mortality associated with TMI and aHSCT
Measured: 30 days from aHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
Measured: 100 days from aHSCT
The late morbidity of TMI
Measured: Beyond 6 months after transplantaton
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2020 (estimated)
- Study completionNov 2025 (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 Ottawa Hospital Research InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold L Atkins, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800059
- Sponsor's protocol ID
- 2008519-01H
- Acronym
- TMI-ASCT
- Status last verified
- Jul 2015
- First submitted
- 27 Nov 2008
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study of Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) for the Treatment of Relapsed or Refractory Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT00800059
- Acronym / sponsor ID
- TMI-ASCT / 2008519-01H
- Conditions
- Multiple Myeloma
- Keywords
- Relapse, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 1 Dec 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.
The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Further,the investigators hypothesize that this will result in an improvement in disease response and disease control for patients with multiple myeloma. This is a dose escalation study of TMI with the primary objective of determining the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Total Marrow IrradiationTreatment with TMI and autologous Stem Cell transplant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment.
- Subject must have primary refractory or relapsed multiple myeloma.
- Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
- Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
- An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation.
Key exclusion criteria (7 listed)
- A subject meeting any of the following criteria is not eligible for participation in the study:
- Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM.
- Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
- Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
- Subjects who have previously received radiation treatments or other neoplastic disorders.
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 |
|---|---|---|
| Total Marrow IrradiationAlso: TMITotal Marrow Irradiation delivered by chemotherapy delivered to cohorts of patients in a dose escalation. The initial cohort will receive 14 Gy. If tolerated subsequent cohorts will receive an additional 2 Gy until the maximum tolerated dose or 28 Gy is reached. | Radiation | Treatment |
Primary outcome
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
Time frame: 30 days from the time of aSCT
4 secondary outcomes
The frequency and timing of engraftment following TMI and aHSCT
Time frame: within 30 days of aHSCT
The early morbidity and mortality associated with TMI and aHSCT
Time frame: 30 days from aHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
Time frame: 100 days from aHSCT
The late morbidity of TMI
Time frame: Beyond 6 months after transplantaton
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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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.
Harold L Atkins, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Total Marrow Irradiation in people with Multiple Myeloma, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 27 Jul 2015. 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 Canada. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma (time frame: 30 days from the time of aSCT). 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 27 Jul 2015.