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

NCT02703779 | Completed Phase 2 Results DMC

• 1 other identifier: 2015-IIT-BMT-MM-AutoSCT
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Bortezomib; Autologous; Stem Cell; Purging; In-vivo purging; Ex-vivo purging; Leukapheresis; Contaminated; Stem Cell Harvest; Stem Cell Transplant; Transplantation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

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

  Within the first 30 days after stem cell collection

• Cluster of Differentiation 34 (CD34) Enumeration

  Within the first 30 days after stem cell collection

Study Arms (2)

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

Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Mozobil

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

Drug: Bortezomib; Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Mozobil

Interventions

Bortezomib DRUG

Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Also known as: VELCADE

Stem cell collection with in-vivo purging with Bortezomib

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.

Also known as: NEUPOGEN, filgrastim, filgrastim-sndz, Zarxio

Stem cell collection with in-vivo purging with Bortezomib; Stem cell collection without in-vivo purging with Bortezomib

Mozobil DRUG

Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

Also known as: plerixafor

Stem cell collection with in-vivo purging with Bortezomib; Stem cell collection without in-vivo purging with Bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siddhartha Ganguly: lead

Study Sites (1)

The University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Granulocyte Colony-Stimulating Factor; Filgrastim; plerixafor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Sid Ganguly
• Organization: University of Kansas Cancer Center

sganguly@kumc.edu

913-588-6030

Study Officials

• Siddhartha Ganguly, MD

  The University of Kansas - Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2016
• Primary Completion: October 4, 2019
• Study Completion: April 8, 2020
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)