A Phase 1 interventional study of Total Marrow Irradiation and Melphalan in Multiple Myeloma, Relapsed and Multiple Myeloma, Refractory to Standard Treatment, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by University of Illinois at Chicago · Phase 1, Interventional, and Treatment
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.
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.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 12 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →University of Illinois at Chicago is the lead sponsor of 523 studies on the registry; 132 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
3Gy with standard high dose melphalan prior to autologous stem cell rescue
Radiation: Total Marrow Irradiation · Drug: Melphalan · Drug: Filgrastim (G-CSF) · Procedure: Autologous transplant
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Radiation: Total Marrow Irradiation · Drug: Melphalan · Drug: Filgrastim (G-CSF) · Procedure: Autologous transplant
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Radiation: Total Marrow Irradiation · Drug: Melphalan · Drug: Filgrastim (G-CSF) · Procedure: Autologous transplant
Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
Also known as: Alkeran ®
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.
Also known as: Neupogen®
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
Also known as: Alkeran ®
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
Also known as: Neupogen®
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
Also known as: Alkeran ®
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
Also known as: Neupogen®
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Maximum Tolerated Dose (MTD) of Gy
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
Time frame: Up to 60 days post-transplant.
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: 1. Normal free light chain ratio (FLC) 2. Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed Complete Response (CR) requires all of the following: 1. 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. 2. Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed. 3. 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) 4. Disappearance of soft tissue plasmacytoma
Time frame: Up to 1 year post-transplant.
| Milestone | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
|---|---|---|---|
| Started | 3 | 3 | 6 |
| Completed | 1 | 0 | 0 |
| Not completed | 2 | 3 | 6 |
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
| Participants | Single Arm |
|---|---|
| Maximum Tolerated Dose (MTD) of Gy | NA |
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: 1. Normal free light chain ratio (FLC) 2. Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed Complete Response (CR) requires all of the following: 1. 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. 2. Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed. 3. 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) 4. Disappearance of soft tissue plasmacytoma
| Participants | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
|---|---|---|---|
| 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 | 1 | 1 | 4 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1Total Marrow Irradiation (TMI) 3Gy | 1/3 (33.3%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 1/3 (33.3%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 1/6 (16.7%) | 1/6 (16.7%) | 3/6 (50%) |
| Event | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
|---|---|---|---|
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 | 1/3 | 1/6 |
| Event | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy |
|---|---|---|---|
| MucositisInfections and infestations | 1/3 | 1/3 | 1/6 |
| NauseaGastrointestinal disorders | 0/3 | 1/3 | 1/6 |
| DiarrheaGastrointestinal disorders | 1/3 | 0/3 | 1/6 |
| Age, Categorical(Participants) | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 0 | 4 | 6 |
| >=65 years | 1 | 3 | 2 | 6 |
| Age, Continuous(Years) | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Total |
|---|---|---|---|---|
| Mean | 59 (56 to 66) | 68 (66 to 69) | 58 (40 to 71) | 61 (40 to 71) |
| Sex: Female, Male(Participants) | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Total |
|---|---|---|---|---|
| Female | 0 | 2 | 2 | 4 |
| Male | 3 | 1 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 2 |
| Not Hispanic or Latino | 1 | 1 | 5 | 7 |
| Unknown or Not Reported | 1 | 2 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 2 | 6 |
| White | 1 | 1 | 4 | 6 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Cohort 1Total Marrow Irradiation (TMI) 3Gy | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Total |
|---|---|---|---|---|
| United States | 3 | 3 | 6 | 12 |
Ran from Jan 2014 to primary completion in Sep 2016, 32 months.
Results were first posted in Oct 2024, 8 years 1 month after primary completion.
Of 197 non-industry phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 99. This study's 32 months is below that.
Counting every sponsor, half of 402 studies reached it within 50 months; a quarter within 32 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melphalan
University of Illinois at Chicago →