Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Melphalan

Lenograstim

Mechlorethamine

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Phenylalanine

Granix on Day -7 through Day -2.

HDM intravenously (IV) on Day -2.

Autologous stem cell transplantation on Day 0

HDM intravenously (IV) on Day -2.

Autologous stem cell transplantation on Day 0.

Granix

High dose melphalan (HDR)

Autologous Stem Cell Transplant (ASCT)

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

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

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

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

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

-Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

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

OS is defined as the duration from the time of transplant Day 0 to death or 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

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.

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.

Washington University School of Medicine

Reportable adverse events are grade 2 or greater events. Hematologic toxicities are expected and therefore the following adverse events will not be collected or reported regardless of grade: anemia, white blood cell decreased, neutrophil count decreased, lymphocyte count decreased, and platelet count decreased. In addition, the following grade 2 non-hematologic adverse events are expected and will not be reported as adverse events: nausea, vomiting, diarrhea, fatigue, or alopecia.

Experimental: Granix and High Dose Melphalan (HDM)

Control: High Dose Melphalan (HDM)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of Participants With Complete Response or Stringent Complete Response

Febrile neutropenia

Atrial fibrillation

Left ventricular systolic function

Sinus tachycardia

Excessive cerumen

Impacted cerumen

Dry eye

Abdominal pain

Colitis

Colonic perforation

Constipation

Diarrhea

Enterocolitis

Epigastric pain

Esophagitis

Hemorrhoids

Ileus

Mucositis oral

Nausea

Oral pain

Upper gastrointestinal hemorrhage

Edema limbs

Fever

Infusion related reaction

Malaise

Pain

Allergic reaction

Bacteremia-Coagulase negative staphyococcus

Bacteremia - Enterobacter Clocae

Bacteremia - Fusobacterium

Bacteremia - MSSA

Bacteremia - Pseudomonas Aeruginosa

Bacteremia - Streptococcus mitis

Candida (groin)

Clostridium difficile

Lung infection

Mucosal infection (oral thrush)

Peri-rectal yeast infection

Sepsis

Skin infection

Splenic infection

Upper respiratory infection

Urinary tract infection

Vaginal infection

Bleeding from CVC insertion site

Fall

Activated partial thromboplastin time prolonged

Aspartate aminotransferase increased

Blood bilirubin increased

Creatinine increased

Electrocardiogram QT corrected interval prolonged

Weight loss

Anorexia

Dehydration

Hypernatremia

Hyperuricemia

Hypoalbuminemia

Hypocalcemia

Hypokalemia

Hyponatremia

Hypophosphatemia

Bone pain

Muscle cramps-back/legs

Right thigh/leg pain

Acitinic Keratosis (right shoulder)

Headache

Reversible posterior leukoencephalopathy syndrome

Syncope

Tremor

Anxiety

Delirium

Insomnia

Hematuria

Proteinuria

Cough

Dyspnea

Hypoxia

Pleural effusion

Pulmonary edema

Wheezing

Erythematous nodules

Pruritus

Rash acneiform

Rash maculo-papular

Skin lesion

Flushing

Hematoma

Hypertension

Hypotension

Phlebitis

Thromboembolic event

Atrial flutter

Myocardial infarction

Palpitations

Supraventricular tachycardia

Adrenal insufficiency

SIADH

Dyspepsia

Dysphagia

Hemorrhoidal hemorrhage

Number of Participants With Adverse Events

Number of Participants With Overall Response

Overall Survival as Measured by Number of Participants Alive at Last Follow-up

Progression-free Survival as Measured by Number of Participants Without Disease Progression at Last Follow-up

Number of Participants With Neutrophil Engraftment

1 participant in control arm did not have a decrease in platelets and is not evaluable for this outcome measure.

Number of Participants With Platelet Engraftment

Overall Study

Spots Global Cancer Trial Database for A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial