Granix to Disrupt the Bone Marrow Microenvironment in Patients with Multiple Myeloma Undergoing Autologous Transplantation

Status: closed to accrual and intervention

This randomized phase II trial compares how well adding filgrastim 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 filgrastim, 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 filgrastim to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma.

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
Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 x 10^6 cluster of differentiation (CD)34+ cells/kg based on patient body weight
Left ventricular ejection fraction at rest >= 40%
Bilirubin =< 2 x upper limit of normal (ULN)
Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 3 x ULN
Creatinine clearance >= 40 mL/minute (measured or calculated/estimated)
Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin [Hgb]) >= 50% of predicted value
Forced expiratory volume in 1 second (FEV1) >= 50% of predicted value
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 institutional review board (IRB)-approved written informed consent document

Exclusion Criteria

Evidence of multiple myeloma disease progression (as defined by International Myeloma Working Group [IMWG]) any time prior to ASCT
Prior stem cell transplant (autologous or allogeneic)
Smoldering multiple myeloma (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 < 7 days prior to the start of treatment on protocol (day -7)

PRIMARY OBJECTIVES:

I. To compare the complete response rate (complete response [CR]+stringent complete response [sCR]) at day 100 of patients treated with Granix (filgrastim) + high dose melphalan (HDM) followed by autologous hematopoietic stem cell transplant (ASCT) to patients treated with HDM alone followed by ASCT.

SECONDARY OBJECTIVES:

I. To compare the toxicity of Granix + HDM to HDM alone.

II. To compare the overall response rate (CR+sCR+very good partial response [VGPR]+partial response [PR]) at day 100 of patients treated with Granix + HDM followed by ASCT to patients treated with HDM alone followed by ASCT.

III. To compare the overall survival of patients treated with Granix + HDM followed by ASCT to patients treated with HDM alone followed by ASCT.

IV. To compare the progression-free survival of patients treated with Granix + HDM followed by ASCT to patients treated with HDM alone followed by ASCT.

V. To compare the rate of neutrophil engraftment of patients treated with Granix + HDM followed by ASCT to patients treated with HDM alone followed by ASCT.

VI. To compare the rate of platelet engraftment of patients treated with Granix + HDM followed by ASCT to patients treated with HDM alone followed by ASCT.

TERTIARY OBJECTIVES:

I. To describe the biological effects of Granix on the bone marrow and changes in the bone marrow cytokine and chemokine levels. This will include: quantification of marrow osteoblasts and C-X-C motif chemokine 12 (CXCL12)-abundant reticular (CAR) cells; measurement of stromal cell-derived factor 1 (SDF-1), CXCL12, interleukin (IL)-6 and B-cell activating factor (BAFF); assessment of myeloma cell proliferation and survival in the bone marrow; assessment of myeloma cell mobilization into the blood by filgrastim (G-CSF).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive filgrastim subcutaneously (SC) on days -7 to -2 and melphalan intravenously (IV) over approximately 30 minutes on day -2. Patients then undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0.

ARM II: Patients receive melphalan and undergo autologous PBSCT as in Arm I.

After completion of study treatment, patients are followed up at 30 and 100 days, and then every 6 months for 2 years.

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Granix to Disrupt the Bone Marrow Microenvironment in Patients with Multiple Myeloma Undergoing Autologous Transplantation

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