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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-0201 | Other Identifier | UIC Office for the Protection of Research Subjects (OPRS) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1Total Marrow Irradiation (TMI) 3Gy | Experimental | 3Gy with standard high dose melphalan prior to autologous stem cell rescue |
|
| Cohort 2 Total Marrow Irradiation (TMI) 6Gy | Experimental | 6Gy with standard high dose melphalan prior to autologous stem cell rescue |
|
| Cohort 3 Total Marrow Irradiation (TMI) 9Gy | Experimental | 9Gy with standard high dose melphalan prior to autologous stem cell rescue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Marrow Irradiation | Radiation | Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Gy | Assessing MTD of TMI of 3Gy, 6Gy and 9Gy | Up to 60 days post-transplant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Complete Response (CR) requires all of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damiano Rondelli, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29065747 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1Total Marrow Irradiation (TMI) 3Gy | 3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
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| Melphalan | Drug | Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant |
|
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| Filgrastim (G-CSF) | Drug | 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. |
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| Autologous transplant | Procedure | Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
|
| Total Marrow Irradiation | Radiation | Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day |
|
| Melphalan | Drug | 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 | 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 transplant | Procedure | Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
|
| Total Marrow Irradiation | Radiation | Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day |
|
| Melphalan | Drug | 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 | 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 |
|
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| Autologous transplant | Procedure | Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
|
| Up to 1 year post-transplant. |
| FG001 | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| FG002 | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1Total Marrow Irradiation (TMI) 3Gy | 3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| BG001 | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| BG002 | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Gy | Assessing MTD of TMI of 3Gy, 6Gy and 9Gy | 3 participants received 3Gy, 3 participants received 6Gy and 6 participants received 9Gy | Posted | Count of Participants | Participants | Up to 60 days post-transplant. |
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| ||||||||||||||||||||||||||
| Secondary | 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:
Complete Response (CR) requires all of the following:
| There was no MTD reached for any Cohort | Posted | Count of Participants | Participants | Up to 1 year post-transplant. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1Total Marrow Irradiation (TMI) 3Gy | 3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue | 1 | 3 | 1 | 3 | 2 | 3 |
| EG001 | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue | 1 | 3 | 1 | 3 | 2 | 3 |
| EG002 | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue | 1 | 6 | 1 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Metastatic prostate cancer(3GY) Progressive myeloma (6Gy and 9Gy) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis | Infections and infestations | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rondelli | University of Illinois at Chicago | 312-996-6179 | drond@uic.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Cohort 2 Total Marrow Irradiation (TMI) 6Gy | 6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
| OG002 | Cohort 3 Total Marrow Irradiation (TMI) 9Gy | 9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): 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 transplant: Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue |
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