Collection of Transplant Stem Cells for Plasma Cell Myeloma

NCT01547806 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 12007412-C-0074
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem cell transplant. Researchers want to collect stem cells from the blood for later transplant. Objectives: \- To collect stem cells for transplant as part of treatment for plasma cell myeloma. Eligibility: \- Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma. Design:

• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
• Participants will have filgrastim injections for 5 days before collection. This will move stem cells from the bone marrow to the blood.
• Participants will have apheresis to collect the stem cells.
• Participants who need additional apheresis procedures to collect stem cells will have filgrastim and a dose of plerixafor to improve the collection yield.

Conditions

Plasma Cell Myeloma; Multiple Myeloma

Keywords

Autologous Hematopoietic Cell Transplantation; Plasma Cell Myeloma; Mobilization; Apheresis; Plerixafor

Outcome Measures

Primary Outcomes (7)

• Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis

  Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE\^6/kg following apheresis.

  Day 1 of apheresis

• Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight

  Progenitor cells by apheresis was determined by flow cytometry.

  Through Day 2 of collection

• Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))

  Progenitor cells by apheresis was determined by flow cytometry.

  Through Day 2 of collection

• Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)

  Progenitor cells by apheresis was determined by flow cytometry.

  Through Day 2 of collection

• Range of Cluster of Differentiation 34 (CD34) Cells Collected

  Progenitor cells by apheresis was determined by flow cytometry.

  Through Day 2 of collection

• 25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected

  Progenitor cells by apheresis was determined by flow cytometry.

  Through Day 2 of collection

• Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)

  The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.

  Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of

Secondary Outcomes (6)

• Number of Participants With Serious and Non-Serious Adverse Events

  27 months and 27 days

• Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)

  One week of mobilization therapy

• Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg

  Through Day 2 of collection

• Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)

  Day one of collection

• Degree of Tumor Cell Contamination in the Final Product

  Day 1 of apheresis

Study Arms (1)

Hematopoietic Progenitor Cells (HPC)

EXPERIMENTAL

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Drug: Filgrastim; Drug: Plerixafor; Procedure: Apheresis

Interventions

Filgrastim DRUG

Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Also known as: Neupogen

Hematopoietic Progenitor Cells (HPC)

Plerixafor DRUG

Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

Also known as: Mozobil

Hematopoietic Progenitor Cells (HPC)

Apheresis PROCEDURE

The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.

Hematopoietic Progenitor Cells (HPC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple Myeloma Criteria:
• Subjects with an indication for autologous hematopoietic cell transplant (AHCT) for the treatment of PCM as determined by the principal investigator (PI) or lead associate investigator (LAI).
• Subjects following induction treatment for plasma cell myeloma (PCM)
• Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM.
• Other Eligibility Criteria:
• Age greater than or equal to 18 years and less than or equal to 75 years. In subjects between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling.
• Karnofsky performance status of 70% or greater (Eastern Cooperative Oncology Group ((ECOG) 0 or 1)
• Ejection fraction (EF) by multigated acquisition scan (MUGA) or 2-D echocardiogram within institution normal limits. In case of low ejection fraction (EF), the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more.
• Hemoglobin (Hgb) greater than or equal to 8 g/dl (transfusion acceptable)
• No history of abnormal bleeding tendency.
• Patients must be able to give informed consent

You may not qualify if:

• Prior allogeneic stem cell transplantation
• Hypertension not adequately controlled by 3 or less medications.
• Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
• Active hepatitis B or C infection
• Human immunodeficiency virus (HIV) seropositive, with positive confirmatory nucleic acid test
• Patients known or found to be pregnant.
• Patients of childbearing age who are unwilling to practice contraception.
• Patients may be excluded at the discretion of the principal investigator (PI)/lead associate investigator (LAI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

  PMID: 18287387 BACKGROUND

• Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9. doi: 10.1002/ajh.2830330203.

  PMID: 2301376 BACKGROUND

• Tosi P, Zamagni E, Cellini C, Plasmati R, Cangini D, Tacchetti P, Perrone G, Pastorelli F, Tura S, Baccarani M, Cavo M. Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma. Eur J Haematol. 2005 Mar;74(3):212-6. doi: 10.1111/j.1600-0609.2004.00382.x.

  PMID: 15693790 BACKGROUND

• Ogunniyi A, Rodriguez M, Devlin S, Adel N, Landau H, Chung DJ, Lendvai N, Lesokhin A, Koehne G, Mailankody S, Korde N, Reich L, Landgren O, Giralt S, Hassoun H. Upfront use of plerixafor and granulocyte-colony stimulating factor (GCSF) for stem cell mobilization in patients with multiple myeloma: efficacy and analysis of risk factors associated with poor stem cell collection efficiency. Leuk Lymphoma. 2017 May;58(5):1123-1129. doi: 10.1080/10428194.2016.1239261. Epub 2016 Oct 13.

  PMID: 27735212 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Filgrastim; plerixafor; Blood Component Removal

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)

Granulocyte Colony-Stimulating Factor; 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; Therapeutics

Limitations and Caveats

The sample size in outcome measure number 6 was inadequate. Results were not conclusive and the information is determined to be too preliminary to present. No conclusion should be drawn from the reported data for this outcome.

Results Point of Contact

• Title: Dr. Jennifer Kanakry
• Organization: National Cancer Institute

kanakryja@nih.gov

301-451-3787

Study Officials

• Jennifer Kanakry, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 8, 2012
• Study Start: February 22, 2012
• Primary Completion: June 17, 2014
• Study Completion: January 11, 2018
• Last Updated: March 7, 2018
• Results First Posted: July 31, 2017

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)