Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma

NCT01074060 | Completed Phase 1 DMC

• 2 other identifiers: 08186NCI-2010-00160
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. This study will assess whether the combination of plerixafor and Granulocyte Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with cyclophosphamide. PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• To assess the MTD ( maximum tolerated dose) of IV plerixafor when given post cyclophosphamide and GCSF for stem cell priming.Dose limiting toxicity will be defined as any grade 3 or 4 nonhematologic toxicity.

  12 to 18 months

• Tolerability and safety of PLERIXAFOR

  Will be summarized in terms of type, severity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.0), date of onset, duration, reversibility, and attribution.

  6 months post transplant

Secondary Outcomes (5)

• Frequency of collecting 5 x 10^6 or more CD34+ cells/kg in 2 or less apheresis days

  5 days post apheresis completion

• Percentage of plasma cells

  5 days post apheresis

• Completion of 100 days post-transplant

  100 days post-transplant

• Overall and disease-free survival

  6months and one year post transplant

• Time to engraftment

  6 months post transplant

Study Arms (1)

Arm I

EXPERIMENTAL

MOBILIZATION: Patients receive cyclophosphamide IV. Patients also receive filgrastim subcutaneously (SC) daily beginning approximately 24 hours later. TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor IV over 30 minutes followed by filgrastim SC on each day of apheresis.

Drug: plerixafor; Biological: filgrastim; Drug: cyclophosphamide; Procedure: autologous hematopoietic stem cell transplantation; Other: laboratory biomarker analysis

Interventions

plerixafor DRUG

Given IV

Also known as: AMD 3100, LM-3100, Mozobil

Arm I

filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, granulocyte colony-stimulating factor, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

Arm I

cyclophosphamide DRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana, Enduxan

Arm I

autologous hematopoietic stem cell transplantation PROCEDURE

autologous hematopoietic stem cell transplantation

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Eligible to undergo autologous transplantation
• Diagnosed with multiple myeloma (MM)
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
• The patient has recovered from all acute toxic effects of prior chemotherapy
• White Blood Count (WBC) \> 2.5 x 10\^9/L
• Absolute neutrophil count \>1.5 x 10\^9/L
• Platelet count \> 100 x 10\^9/L
• Serum creatinine \<= 2.5 mg/dl
• Creatinine clearance \>= 50 ml/min (measured or calculated)
• Serum glutamic oxaloacetic transaminase (SGOT) \< 2 x ULN (Upper Limit of Normal)
• Serum glutamic pyruvic transaminase (SGPT) \< 2 x ULN
• Total bilirubin \< 2 x ULN
• Left ventricle ejection fraction \> 45% \[by normal ECHO (Echocardiogram) or MUGA (MUltiple Gated Acquisition) scan\]
• FEV1 (forced expiratory volume in 1 second) \> 60% of predicted or DLCO (Carbon Monoxide Diffusing Capacity )\> 55% of predicted
• No active infection of hepatitis B or C

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

plerixafor; Filgrastim; Granulocyte Colony-Stimulating Factor; Cyclophosphamide

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)

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Amrita Krishnan

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 24, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)