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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02112045
• Other study ID #: 201405057
• Status: Terminated
• Phase: Phase 2
• Start date: January 20, 2015
• Est. completion date: September 10, 2019

Study information

• Verified date: November 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: September 10, 2019
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Granix

• High dose melphalan (HDR)

Procedure:
• Autologous Stem Cell Transplant (ASCT)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Response or Stringent Complete Response	Complete response (CR) requires all of the following: Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine; <5% plasma cells in the bone marrow; Disappearance of soft tissue plasmacytomas; Stringent complete response (sCR) requires all of the following: CR as defined above; Normal free light chain ratio; Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence	Day +100
Secondary	Number of Participants With Adverse Events	-Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	Up through Day 30
Secondary	Number of Participants With Overall Response	Overall response rate=CR+sCR+VGPR+PR; Complete response (CR), disappearance of monoclonal protein from the blood & urine and <5% plasma cells in bone marrow &disappearance of soft tissue plasmacytomas; Stringent complete response (sCR), CR & normal free light chain ratio & absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very good partial response (VGPR), serum and urine monoclonal protein detectable by immunofixation but not on electrophoresis OR > 90% reduction in serum monoclonal protein with urine monoclonal protein < 100 mg per 24 hours and if present, > 50% reduction in the size of soft tissue plasmacytomas; Partial response (PR), > 50% reduction in the level of the serum monoclonal protein & reduction in urine monoclonal protein & > 50% reduction in the size of soft tissue plasmacytomas & if serum and urine monoclonal protein are unmeasurable and serum free light chain is unmeasurable, a > 50% reduction in plasma cells is required	Up to 2 years
Secondary	Overall Survival as Measured by Number of Participants Alive at Last Follow-up	OS is defined as the duration from the time of transplant Day 0 to death or last follow-up.	Up to 2 years
Secondary	Progression-free Survival as Measured by Number of Participants Without Disease Progression at Last Follow-up	PFS is defined as the duration from time of transplant Day 0 to time of first progression/clinical relapse, death, or the date the patient was last known to be in remission	Up to 2 years
Secondary	Number of Participants With Neutrophil Engraftment	Neutrophil engraftment is defined as ANC = 0.5 × 10^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC = 0.5 × 109/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.	Up to Day 30
Secondary	Number of Participants With Platelet Engraftment	Platelet engraftment is defined as an untransfused platelet measurement >20,000/mm3 × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is >20,000/mm3 will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.	Up to Day 100

External Links

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