NCT02703779 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-06-18

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Multiparametric Flow Cytometry - Minimum Residual Disease

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outcome · POSTED

Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment

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outcome · POSTED

Cluster of Differentiation 34 (CD34) Enumeration

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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
intervention Names
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Mozobil
label
Stem cell collection without in-vivo purging with Bortezomib
type
ACTIVE_COMPARATOR
description
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
intervention Names
Drug: Bortezomib
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Mozobil
label
Stem cell collection with in-vivo purging with Bortezomib
type
EXPERIMENTAL

interventions

arm Group Labels
Stem cell collection with in-vivo purging with Bortezomib
description
Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.
name
Bortezomib
other Names
VELCADE
type
DRUG
arm Group Labels
Stem cell collection with in-vivo purging with Bortezomib
Stem cell collection without in-vivo purging with Bortezomib
description
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.
name
Granulocyte colony-stimulating factor (G-CSF)
other Names
NEUPOGEN
filgrastim
filgrastim-sndz
Zarxio
type
DRUG
arm Group Labels
Stem cell collection with in-vivo purging with Bortezomib
Stem cell collection without in-vivo purging with Bortezomib
description
Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
name
Mozobil
other Names
plerixafor
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 101
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

secondary Outcomes

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.
measure
Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
time Frame
Within the first 30 days after stem cell collection
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.
measure
Cluster of Differentiation 34 (CD34) Enumeration
time Frame
Within the first 30 days after stem cell collection

Full study description

brief Summary: Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.
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).

Source references

references

citation
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.
pmid
18268286
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice