Multiple Myeloma, RelapsedPhase 1BMT-03NCT02043847
TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)
A Phase 1 study testing Total Marrow Irradiation, Melphalan and Filgrastim (G-CSF) in people with Multiple Myeloma, Relapsed and Multiple Myeloma, Refractory to Standard Treatment, run by University of Illinois Chicago at 1 site in United States.
Trial summary
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Relapsed, Multiple Myeloma, Refractory to Standard Treatment
- What is being tested?
- Total Marrow Irradiation, Melphalan and Filgrastim (G-CSF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2014to 14 Sep 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting criteria for symptomatic myeloma
- Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- Cardiac function: LVEF >40%
- Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- Renal: Creatinine clearance of >30mL/min, estimated or calculated
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Who cannot join
- Patients with diagnosis of plasma cell leukemia
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Pregnant or breast-feeding
- Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
- Patients who have undergone prior allogeneic stem cell transplant
- Prior solid organ transplant
- Patients receiving prior radiation to more than 20% of bone marrow containing areas
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Cancer Center
Chicago, Illinois, 60612
About this study
Official title: BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.
Read the detailed description
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 9Gy.
- Being tested
- Total Marrow Irradiation, Melphalan, Filgrastim (G-CSF), Autologous transplant
- Keywords
- Multiple Myeloma, Relapsed, Refractory, Progressive Disease, Symptomatic
- Medical subject headings
- Multiple Myeloma, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Marrow IrradiationRadiation
Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day
MelphalanDrug
Also called Alkeran ®
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Filgrastim (G-CSF)Drug
Also called Neupogen®
Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days.
Autologous transplantProcedure or surgery
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
Total Marrow IrradiationRadiation
Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
MelphalanDrug
Also called Alkeran ®
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Filgrastim (G-CSF)Drug
Also called Neupogen®
Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days
Autologous transplantProcedure or surgery
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
Total Marrow IrradiationRadiation
Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
MelphalanDrug
Also called Alkeran ®
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Filgrastim (G-CSF)Drug
Also called Neupogen®
Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days
Autologous transplantProcedure or surgery
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1Total Marrow Irradiation (TMI) 3Gy | Experimental | 3Gy with standard high dose melphalan prior to autologous stem cell rescue Receives: Radiation: Total Marrow Irradiation; Drug: Melphalan; Drug: Filgrastim (G-CSF); Procedure: Autologous transplant |
| Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Experimental | 6Gy with standard high dose melphalan prior to autologous stem cell rescue Receives: Radiation: Total Marrow Irradiation; Drug: Melphalan; Drug: Filgrastim (G-CSF); Procedure: Autologous transplant |
| Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Experimental | 9Gy with standard high dose melphalan prior to autologous stem cell rescue Receives: Radiation: Total Marrow Irradiation; Drug: Melphalan; Drug: Filgrastim (G-CSF); Procedure: Autologous transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Gy
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
Measured: Up to 60 days post-transplant.
Secondary outcomes (1)
Progression Free Survival (PFS) and in Patients With Multiple Myeloma (Relapsed or Refractory) Undergoing Autologous Stem Cell Transplant Using the Combination of High Dose Melphalan and Total Marrow Irradiation
The disease status of enrolled patients will be evaluated based on the International Myeloma Working Group Criteria.
Response Criteria
Stringent Complete Response (sCR) in addition to CR all of the following:
- Normal free light chain ratio (FLC)
- Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed
Complete Response (CR) requires all of the following:
- Absence of the original monoclonal paraprotein in the serum or the urine by routine electrophoresis and by immunofixation. The presence of new monoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.
- Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed.
- No increase in size or number of lytic bone lesions on radiologic investigation (development of compression fracture does not exclude CR and radiographs are not required to document CR if not clinically indicated)
- Disappearance of soft tissue plasmacytoma
Measured: Up to 1 year post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start14 Jan 2014
- Primary completion14 Sep 2016
- Study completion14 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma, RelapsedStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damiano Rondelli, MD, University of Illinois Chicago
- Investigators
- Damiano Rondelli, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043847
- Sponsor's protocol ID
- 2013-0201
- Other IDs
- 2013-0201
- Acronym
- BMT-03
- Status last verified
- Oct 2024
- First submitted
- 21 Jan 2014
- Last updated
- 13 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Patel P, Oh AL, Koshy M, Sweiss K, Saraf SL, Quigley JG, Khan I, Mahmud N, Hacker E, Ozer H, Peace DJ, Weichselbaum RR, Aydogan B, Rondelli D. A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m2 and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma. Leuk Lymphoma. 2018 Jul;59(7):1666-1671. doi: 10.1080/10428194.2017.1390231. Epub 2017 Oct 25.
PubMed 29065747
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02043847
- Acronym / sponsor ID
- BMT-03 / 2013-0201
- Keywords
- Multiple Myeloma, Relapsed, Refractory, Progressive Disease, Symptomatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 14 Sep 2016 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.
Detailed description
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 9Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1Total Marrow Irradiation (TMI) 3Gy | Experimental | Radiation: Total Marrow Irradiation, Drug: Melphalan, Drug: Filgrastim (G-CSF), Procedure: Autologous transplant3Gy with standard high dose melphalan prior to autologous stem cell rescue |
| Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Experimental | Radiation: Total Marrow Irradiation, Drug: Melphalan, Drug: Filgrastim (G-CSF), Procedure: Autologous transplant6Gy with standard high dose melphalan prior to autologous stem cell rescue |
| Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Experimental | Radiation: Total Marrow Irradiation, Drug: Melphalan, Drug: Filgrastim (G-CSF), Procedure: Autologous transplant9Gy with standard high dose melphalan prior to autologous stem cell rescue |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients meeting criteria for symptomatic myeloma
- Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- Cardiac function: LVEF >40%
Key exclusion criteria (7 listed)
- Patients with diagnosis of plasma cell leukemia
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Pregnant or breast-feeding
- Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
- Patients who have undergone prior allogeneic stem cell transplant
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 IrradiationSubjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day | Radiation | Cohort 1Total Marrow Irradiation (TMI) 3Gy |
| MelphalanAlso: Alkeran ®Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant | Drug | Cohort 1Total Marrow Irradiation (TMI) 3Gy |
| Filgrastim (G-CSF)Also: Neupogen®Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days. | Drug | Cohort 1Total Marrow Irradiation (TMI) 3Gy |
| Autologous transplantSubjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue | Procedure or surgery | Cohort 1Total Marrow Irradiation (TMI) 3Gy |
| Total Marrow IrradiationSubjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day | Radiation | Cohort 2 Total Marrow Irradiation (TMI) 6Gy |
| MelphalanAlso: Alkeran ®Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant | Drug | Cohort 2 Total Marrow Irradiation (TMI) 6Gy |
| Filgrastim (G-CSF)Also: Neupogen®Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days | Drug | Cohort 2 Total Marrow Irradiation (TMI) 6Gy |
| Autologous transplantSubjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue | Procedure or surgery | Cohort 2 Total Marrow Irradiation (TMI) 6Gy |
| Total Marrow IrradiationSubjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day | Radiation | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
| MelphalanAlso: Alkeran ®Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant | Drug | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
| Filgrastim (G-CSF)Also: Neupogen®Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days | Drug | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
| Autologous transplantSubjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue | Procedure or surgery | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
Primary outcome
Maximum Tolerated Dose (MTD) of Gy
Time frame: Up to 60 days post-transplant.
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
1 secondary outcome
Progression Free Survival (PFS) and in Patients With Multiple Myeloma (Relapsed or Refractory) Undergoing Autologous Stem Cell Transplant Using the Combination of High Dose Melphalan and Total Marrow Irradiation
Time frame: Up to 1 year post-transplant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29065747Patel P, Oh AL, Koshy M, Sweiss K, Saraf SL, Quigley JG, Khan I, Mahmud N, Hacker E, Ozer H, Peace DJ, Weichselbaum RR, Aydogan B, Rondelli D. A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m2 and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma. Leuk Lymphoma. 2018 Jul;59(7):1666-1671. doi: 10.1080/10428194.2017.1390231. Epub 2017 Oct 25.
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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.
Damiano Rondelli, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Total Marrow Irradiation, Melphalan and Filgrastim (G-CSF) in people with Multiple Myeloma, Relapsed and Multiple Myeloma, Refractory to Standard Treatment, run by University of Illinois Chicago 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 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: finished, as of the sponsor's last update on 13 Nov 2024. 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 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?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) of Gy (time frame: Up to 60 days post-transplant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043847, which also lists 1 linked publication.
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 13 Nov 2024.