| ID | Type | Description | Link |
|---|---|---|---|
| MT2003-13 | Other Identifier | Blood and Marrow Transplantation Program | |
| 0312M54569 | Other Identifier | IRB, University of Minnesota |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy and Transplant Treatment | Experimental | Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Transplant | Procedure | As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR:
Complete Response (CR):
| 100 Days post transplant |
| Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR:
Complete Response (CR):
| 6 months post transplant |
| Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR:
Complete Response (CR):
| 12 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Extended Disease-free Survival | Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression. | 36 Months |
| Number of Participants With Overall Survival |
Not provided
Inclusion Criteria:
Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:
Is not eligible or has refused any protocols of higher priority
18 - 75 years of age
Adequate organ function defined as:
Free of active uncontrolled infection at the time of study entry.
At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudio Brunstein, MD, PhD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy and Transplant Treatment | Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy and Transplant Treatment | Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate. |
| 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 |
| 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 | Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR:
Complete Response (CR):
| 173 participants were not evaluable | Posted | Count of Participants | Participants | 100 Days post transplant |
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy and Transplant Treatment | Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate. Stem Cell Transplant: As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. Cyclophosphamide + Mesna: Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs. Melphalan: Administered intravenously 200 mg/m^2 Granulocyte-colony stimulating factor: Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| M-spike increase | Investigations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Claudio G. Brunstein MD, PhD | Masonic Cancer Center, University of Minnesota | 612-625-3918 | bruns072@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2017 | Aug 3, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D016026 | Bone Marrow Transplantation |
| D003520 | Cyclophosphamide |
| D015080 | Mesna |
| D008558 | Melphalan |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Cyclophosphamide + Mesna | Drug | Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs. |
|
|
| Melphalan | Drug | Administered intravenously 200 mg/m^2 |
|
|
| Granulocyte-colony stimulating factor | Biological | Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant. |
|
|
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. |
| 1 year |
| Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | 2 years |
| Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | 3 years |
| Count of Participants Experiencing Transplant Related Mortality | In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation. | 1 year |
| Number of Participants Experiencing Incidence of Relapse | The return of disease after its apparent recovery/cessation. | 1 year |
| Number of Participants With Disease Progression | Myeloma Response Definitions - Using International Uniform Response Criteria: Progressive Disease (PD) For patients not in CR or sCR, progressive disease requires one or more of the following:
| 1 year |
| Time to Progression | Mean number of days among patients progressing | 1 year |
| Time to Relapse | Mean number of days among patients relapsing | 1 year |
| Number of Participants With Absolute Neutrophil Recovery | Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/μl and platelets > 100,000/μl | Day 42 |
| Time to Attainment of CR | Mean (STD) among patients achieving complete remission (CR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR):
| 12 months post transplant |
| Time to Attainment of CR+PR | Mean (STD) among patients achieving complete remission (CR) and partial remission (PR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR):
Partial Response (PR):
| 12 months post transplant |
| Duration of Maintenance Treatment | During study |
| Dropout Rate From Maintenance Therapy | Post transplant phase |
| Number of Participants With Toxicities | Occurrence of toxicities by first 100 days of transplant | By first 100 days |
| Number of Participants With Infections | Occurrence of infections in the patients by the first 100 days of transplant | By first 100 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR:
Complete Response (CR):
| 54 participants were not evaluable | Posted | Count of Participants | Participants | 6 months post transplant |
|
|
|
| Primary | Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR:
Complete Response (CR):
| 55 participants were not evaluable | Posted | Count of Participants | Participants | 12 months post transplant |
|
|
|
| Secondary | Number of Patients With Extended Disease-free Survival | Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression. | Posted | Count of Participants | Participants | 36 Months |
|
|
|
| Secondary | Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Count of Participants Experiencing Transplant Related Mortality | In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Participants Experiencing Incidence of Relapse | The return of disease after its apparent recovery/cessation. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Participants With Disease Progression | Myeloma Response Definitions - Using International Uniform Response Criteria: Progressive Disease (PD) For patients not in CR or sCR, progressive disease requires one or more of the following:
| Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Time to Progression | Mean number of days among patients progressing | Posted | Mean | Standard Deviation | Days | 1 year |
|
|
|
| Secondary | Time to Relapse | Mean number of days among patients relapsing | Posted | Mean | Standard Deviation | Days | 1 year |
|
|
|
| Secondary | Number of Participants With Absolute Neutrophil Recovery | Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/μl and platelets > 100,000/μl | Posted | Count of Participants | Participants | Day 42 |
|
|
|
| Secondary | Time to Attainment of CR | Mean (STD) among patients achieving complete remission (CR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR):
| Data was not available on everyone for this endpoint so could only evaluable for 308 out of 363 patients due to data for participants is not available as the EPIC system was not in place when this study was conducted and participants moved to different clinics we do not have follow-up details. | Posted | Mean | Standard Deviation | months | 12 months post transplant |
|
|
|
| Secondary | Time to Attainment of CR+PR | Mean (STD) among patients achieving complete remission (CR) and partial remission (PR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR):
Partial Response (PR):
| 55 patients were not evaluable Data was not available on everyone for this endpoint so could not evaluate all 363 patients | Posted | Mean | Standard Deviation | months | 12 months post transplant |
|
|
|
| Secondary | Duration of Maintenance Treatment | Data not available for this outcome at our center, maintenance treatment data for participants is not available as the EPIC system was not in place when this study was conducted and participants moved to different clinics so follow-up details were no available. | Posted | During study |
|
|
| Secondary | Dropout Rate From Maintenance Therapy | Data not available for this outcome at our center, maintenance treatment data for participants is not available as the EPIC system was not in place when this study was conducted and participants moved to different clinics so follow-up details were no available. | Posted | Post transplant phase |
|
|
| Secondary | Number of Participants With Toxicities | Occurrence of toxicities by first 100 days of transplant | Posted | Count of Participants | Participants | By first 100 days |
|
|
|
| Secondary | Number of Participants With Infections | Occurrence of infections in the patients by the first 100 days of transplant | Posted | Count of Participants | Participants | By first 100 days |
|
|
|
| 62 |
| 363 |
| 2 |
| 363 |
| 194 |
| 363 |
| GI bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Akinesis | Nervous system disorders | Non-systematic Assessment |
|
| Edema | Renal and urinary disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Artrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Blood clot | Vascular disorders | Non-systematic Assessment |
|
| bowl obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Chest opacities | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Cytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Elevated troponin | Investigations | Non-systematic Assessment |
|
| Emphysema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Encephalopathy | Hepatobiliary disorders | Non-systematic Assessment |
|
| Engraftment syndrome | General disorders | Non-systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eye hemorrhage | Eye disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| GI toxicity | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gout | Immune system disorders | Non-systematic Assessment |
|
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Heart abnormality | Cardiac disorders | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Hernia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypercalcemia | Investigations | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Hypothyroidism | Investigations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Intubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Left hio hemiarhroplasty | Surgical and medical procedures | Non-systematic Assessment |
|
| Left vertricular hypertrophy | Cardiac disorders | Non-systematic Assessment |
|
| Liver parenchymal disease | Hepatobiliary disorders | Non-systematic Assessment |
|
| Low Ejection fraction | Cardiac disorders | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Muscle tear | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | Non-systematic Assessment |
|
| Ocular muscle fatigue | Eye disorders | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Physical Deconditioning | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Plueral effusions | Cardiac disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rashes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Renal calculus | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal insufficiency | Renal and urinary disorders | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| skin; stevens Johnson syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| stent placement for occlusion | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Transminitis | Investigations | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| 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 |