A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation

NCT ID: NCT02112045

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-20
• Study Completion Date: 2019-09-10

Brief Summary

This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple myeloma cells move from the patient's bone marrow to the blood where they may be more sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Granix and high dose melphalan (HDM)

Granix on Day -7 through Day -2.

HDM intravenously (IV) on Day -2.

Autologous stem cell transplantation on Day 0

Group Type: EXPERIMENTAL

Granix

Intervention Type: DRUG

High dose melphalan (HDR)

Intervention Type: DRUG

Autologous Stem Cell Transplant (ASCT)

Intervention Type: PROCEDURE

Control: High dose melphalan (HDM)

HDM intravenously (IV) on Day -2.

Autologous stem cell transplantation on Day 0.

Group Type: ACTIVE_COMPARATOR

High dose melphalan (HDR)

Intervention Type: DRUG

Autologous Stem Cell Transplant (ASCT)

Intervention Type: PROCEDURE

Interventions

Granix

Intervention Type: DRUG

High dose melphalan (HDR)

Intervention Type: DRUG

Autologous Stem Cell Transplant (ASCT)

Intervention Type: PROCEDURE

Other Intervention Names

XM02 filgrastim; Alkeran® Tablets; Phenylalanine mustard

Eligibility Criteria

Inclusion Criteria

• Symptomatic multiple myeloma requiring treatment
• Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy
• At least 18 years of age
• Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 × 10^6 CD34+ cells/kg based on patient body weight.
• Adequate organ function as measured by:

• Cardiac function: Left ventricular ejection fraction at rest ≥40%
• Hepatic function: Bilirubin ≤2 × ULN and aspartate amino transferase/alanine amino transferase (AST/ALT) ≤3 × ULN
• Renal function: Creatinine clearance ≥40 mL/minute (measured or calculated/estimated)
• Pulmonary function: Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin [Hgb]), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC) ≥50% of predicted value
• Oxygen saturation ≥92% on room air
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria

• Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to ASCT
• Prior stem cell transplant (autologous or allogeneic)
• Smoldering MM not requiring therapy
• Plasma cell leukemia
• Systemic amyloid light chain amyloidosis
• Active bacterial, viral, or fungal infection
• Seropositive for human immunodeficiency virus (HIV)
• Known, active hepatitis A, B, or C Infection
• Pregnant or breastfeeding.
• Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on Day +100.
• Hypersensitive or intolerant to any component of the study drug(s) formulation
• Receiving growth factors (filgrastim, XM02-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis < 14 days prior to the start of treatment on protocol (Day -7).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meagan Jacoby, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201405057

Identifier Type: -

Identifier Source: org_study_id