Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)

• Sponsor: Siddhartha Ganguly (Other)
• Overall Status: Completed
• CT.gov ID: NCT02703779
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Actual Duration (Months): 49.2
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Bortezomib; Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Mozobil	Phase 2

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Oct 4, 2019
• Actual Study Completion Date: Apr 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: 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.; Other Names: NEUPOGEN filgrastim filgrastim-sndz Zarxio ; Drug: Mozobil; Mozobil will be given to all participants by injection under the skin only if needed per Investigator.; Other Names: plerixafor
Experimental: 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	Drug: Bortezomib; Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.; Other Names: VELCADE ; Drug: 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.; Other Names: NEUPOGEN filgrastim filgrastim-sndz Zarxio ; Drug: Mozobil; Mozobil will be given to all participants by injection under the skin only if needed per Investigator.; Other Names: plerixafor

Outcome Measures

Primary Outcome Measures

1. Multiparametric Flow Cytometry - Minimum Residual Disease [Day 0 for all subjects (Day 0 is the day of stem cell collection)]

   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.

Secondary Outcome Measures

1. Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment [Within the first 30 days after stem cell collection]

   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.

2. Cluster of Differentiation 34 (CD34) Enumeration [Within the first 30 days after stem cell collection]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• leukocytes ≥ 3,000/micro Liter (mcL)

• absolute neutrophil count ≥ 1,500/mcL

• platelets ≥ 100,000/mcL

• total bilirubin within normal institutional limits NOTE: For this study, subjects with bilirubin levels > 1.5 Upper Limit of Normal (ULN) are excluded from enrollment in this study.

• Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase [SGOT]) ≤ 2.5 X institutional upper limit of normal

• Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 2.5 X institutional upper limit of normal

• creatinine within normal institutional limits

• 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:

• Has not undergone a hysterectomy or bilateral oophorectomy; or

• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria:

• Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.

• Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy:

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

• ongoing or active infection

• symptomatic congestive heart failure

• unstable angina pectoris

• cardiac arrhythmia

• psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Kansas Medical Center	Westwood	Kansas	United States	66205

Sponsors and Collaborators

• Siddhartha Ganguly

Investigators

• Principal Investigator: Siddhartha Ganguly, MD, The University of Kansas - Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 21, 2016
• Informed Consent Form - May 28, 2019

More Information

Publications

• 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, Omedé 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.

• Responsible Party: Siddhartha Ganguly, Medical Doctor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT02703779
• Other Study ID Numbers: 2015-IIT-BMT-MM-AutoSCT
• First Posted: Mar 9, 2016
• Last Update Posted: Jun 18, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Siddhartha Ganguly, Medical Doctor, University of Kansas Medical Center: Multiple Myeloma; Bortezomib; Autologous; Stem Cell; Purging; In-vivo purging; Ex-vivo purging; Leukapheresis; Contaminated; Stem Cell Harvest; Stem Cell Transplant; Transplantation
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plerixafor; Bortezomib; Lenograstim

Study Results

Participant Flow

Arm/Group Title	Stem Cell Collection Without In-vivo Purging With Bortezomib	Stem Cell Collection With In-vivo Purging With Bortezomib
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	51	50
COMPLETED	51	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Stem Cell Collection Without In-vivo Purging With Bortezomib	Stem Cell Collection With In-vivo Purging With Bortezomib	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	51	50	101
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	37 72.5%	29 58%	66 65.3%
>=65 years	14 27.5%	21 42%	35 34.7%
Sex: Female, Male (Count of Participants)
Female	21 41.2%	21 42%	42 41.6%
Male	30 58.8%	29 58%	59 58.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2%	4 8%	5 5%
Not Hispanic or Latino	49 96.1%	46 92%	95 94.1%
Unknown or Not Reported	1 2%	0 0%	1 1%

Outcome Measures

1. Primary Outcome

Title	Multiparametric Flow Cytometry - Minimum Residual Disease
Description	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.
Time Frame	Day 0 for all subjects (Day 0 is the day of stem cell collection)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Collection Without In-vivo Purging With Bortezomib	Stem Cell Collection With In-vivo Purging With Bortezomib
Arm/Group Description	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.	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.
Measure Participants	51	50
Count of Participants [Participants]	11 21.6%	13 26%

2. Secondary Outcome

Title	Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
Description	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.
Time Frame	Within the first 30 days after stem cell collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Collection Without In-vivo Purging With Bortezomib	Stem Cell Collection With In-vivo Purging With Bortezomib
Arm/Group Description	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.	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.
Measure Participants	51	50
Count of Participants [Participants]	51 100%	50 100%

3. Secondary Outcome

Title	Cluster of Differentiation 34 (CD34) Enumeration
Description	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.
Time Frame	Within the first 30 days after stem cell collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Collection Without In-vivo Purging With Bortezomib	Stem Cell Collection With In-vivo Purging With Bortezomib
Arm/Group Description	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.	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.
Measure Participants	51	50
Mean (Standard Deviation) [percentage of CD34 positive cells]	8.9 (0.1)	7.8 (0.1)

Adverse Events

Time Frame	From the time of signing the consent until 30 days after collection or up to 2 months.
Arm/Group Title	Stem Cell Collection Without In-vivo Purging With Bortezomib		Stem Cell Collection With In-vivo Purging With Bortezomib
Arm/Group Description	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.		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.
All Cause Mortality
	Stem Cell Collection Without In-vivo Purging With Bortezomib		Stem Cell Collection With In-vivo Purging With Bortezomib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/51 (5.9%)		1/50 (2%)
Serious Adverse Events
	Stem Cell Collection Without In-vivo Purging With Bortezomib		Stem Cell Collection With In-vivo Purging With Bortezomib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/51 (23.5%)		24/50 (48%)
Blood and lymphatic system disorders
Febrile neutropenia	8/51 (15.7%)	8	7/50 (14%)	7
Cardiac disorders
Atrial fibrillation	1/51 (2%)	1	2/50 (4%)	2
Gastrointestinal disorders
Diarrhea	1/51 (2%)	1	1/50 (2%)	1
Enterocolitis	1/51 (2%)	1	0/50 (0%)	0
Abdominal pain	0/51 (0%)	0	1/50 (2%)	1
Mucositis oral	0/51 (0%)	0	4/50 (8%)	4
General disorders
Fatigue	1/51 (2%)	1	0/50 (0%)	0
Fever	0/51 (0%)	0	1/50 (2%)	1
Infections and infestations
Infection	0/51 (0%)	0	1/50 (2%)	1
Sepsis	0/51 (0%)	0	1/50 (2%)	1
Nervous system disorders
Peripheral sensory neuropathy	0/51 (0%)	0	1/50 (2%)	1
Syncope	0/51 (0%)	0	2/50 (4%)	2
Renal and urinary disorders
Acute kidney injury	0/51 (0%)	0	1/50 (2%)	1
Vascular disorders
Hypotension	0/51 (0%)	0	2/50 (4%)	2
Other (Not Including Serious) Adverse Events
	Stem Cell Collection Without In-vivo Purging With Bortezomib		Stem Cell Collection With In-vivo Purging With Bortezomib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/51 (76.5%)		39/50 (78%)
Blood and lymphatic system disorders
Anemia	9/51 (17.6%)	26	7/50 (14%)	8
Gastrointestinal disorders
Constipation	15/51 (29.4%)	16	14/50 (28%)	14
Diarrhea	29/51 (56.9%)	55	29/50 (58%)	45
Mucositis oral	20/51 (39.2%)	27	18/50 (36%)	28
Nausea	33/51 (64.7%)	59	29/50 (58%)	45
Vomiting	24/51 (47.1%)	37	21/50 (42%)	27
General disorders
Edema limbs	12/51 (23.5%)	14	10/50 (20%)	11
Fatigue	21/51 (41.2%)	32	21/50 (42%)	30
Investigations
Neutrophil count decreased	21/51 (41.2%)	37	16/50 (32%)	24
Platelet count decreased	25/51 (49%)	68	18/50 (36%)	24
White blood cell decreased	27/51 (52.9%)	46	23/50 (46%)	46
Metabolism and nutrition disorders
Anorexia	26/51 (51%)	34	27/50 (54%)	33
Hypokalemia	27/51 (52.9%)	53	19/50 (38%)	43
Hypomagnesemia	14/51 (27.5%)	16	7/50 (14%)	13
Hyponatremia	9/51 (17.6%)	16	7/50 (14%)	9
Musculoskeletal and connective tissue disorders
Back pain	9/51 (17.6%)	11	8/50 (16%)	10
Bone pain	10/51 (19.6%)	10	6/50 (12%)	7
Generalized muscle weakness	11/51 (21.6%)	12	15/50 (30%)	16
Psychiatric disorders
Anxiety	11/51 (21.6%)	11	9/50 (18%)	10
Insomnia	13/51 (25.5%)	15	4/50 (8%)	4
Respiratory, thoracic and mediastinal disorders
Dyspnea	12/51 (23.5%)	12	6/50 (12%)	7
Vascular disorders
Hypertension	9/51 (17.6%)	14	4/50 (8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.