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Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.
High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort.
The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients.
The study will consist of two groups:
Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.
Group B: Bortezomib 1.3mg/m^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell collection without in-vivo purging with Bortezomib | Active Comparator | Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B |
|
| Stem cell collection with in-vivo purging with Bortezomib | Experimental | Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multiparametric Flow Cytometry - Minimum Residual Disease | Estimate the proportion of subjects with plasma cell contamination (defined as >0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil. | Day 0 for all subjects (Day 0 is the day of stem cell collection) |
| Measure | Description | Time Frame |
|---|---|---|
| Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment | Estimate the proportion of subjects who have a successful collection of stem cells (> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups. | Within the first 30 days after stem cell collection |
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Inclusion Criteria:
Subjects must meet all of the inclusion criteria to participate in this study.
Ability to understand, and the willingness to sign a written Informed Consent Form
Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation
Age ≥ 18 years
Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
Adequate organ and marrow function as defined below:
Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization.
Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF)
Subject has received > 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection
Subject has known brain metastases. Presence of brain metastases should be excluded from this clinical trial because of poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Grade 3 or higher peripheral neuropathy
Bilirubin levels > 1.5 ULN
Uncontrolled inter-current illness including, but not limited to
Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
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| Name | Affiliation | Role |
|---|---|---|
| Siddhartha Ganguly, MD | The University of Kansas - Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18268286 | Background | Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008 Mar;93(3):431-8. doi: 10.3324/haematol.11080. Epub 2008 Feb 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stem Cell Collection Without In-vivo Purging With Bortezomib | Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Nov 21, 2016 |
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| Granulocyte colony-stimulating factor (G-CSF) | Drug | Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. |
|
|
| Mozobil | Drug | Mozobil will be given to all participants by injection under the skin only if needed per Investigator. |
|
|
| Cluster of Differentiation 34 (CD34) Enumeration | Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection. | Within the first 30 days after stem cell collection |
| FG001 | Stem Cell Collection With In-vivo Purging With Bortezomib | Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stem Cell Collection Without In-vivo Purging With Bortezomib | Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. |
| BG001 | Stem Cell Collection With In-vivo Purging With Bortezomib | Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. |
| BG002 | 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 |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Multiparametric Flow Cytometry - Minimum Residual Disease | Estimate the proportion of subjects with plasma cell contamination (defined as >0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil. | Posted | Count of Participants | Participants | No | Day 0 for all subjects (Day 0 is the day of stem cell collection) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment | Estimate the proportion of subjects who have a successful collection of stem cells (> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups. | Posted | Count of Participants | Participants | No | Within the first 30 days after stem cell collection |
| |||||||||||||||||||||||||||||||
| Secondary | Cluster of Differentiation 34 (CD34) Enumeration | Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection. | Posted | Mean | Standard Deviation | percentage of CD34 positive cells | Within the first 30 days after stem cell collection |
|
From the time of signing the consent until 30 days after collection or up to 2 months.
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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 | Stem Cell Collection Without In-vivo Purging With Bortezomib | Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed). NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. | 3 | 51 | 12 | 51 | 39 | 51 |
| EG001 | Stem Cell Collection With In-vivo Purging With Bortezomib | Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed. There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection. Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed. Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator. | 1 | 50 | 24 | 50 | 39 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema limbs | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sid Ganguly | University of Kansas Cancer Center | 913-588-6030 | sganguly@kumc.edu |
| Apr 27, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2019 | Apr 27, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| 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 |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| C088327 | plerixafor |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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