Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00651937

Purpose

Primary Objective:

Determine differences in post transplant symptom burden as measured by M.D. Anderson Symptom Inventory (MDASI) scores in older patients with myeloma, or patients with amyloidosis undergoing high dose melphalan therapy receiving high dose melphalan with either a standard CD34+ cell dose of 4-6 x 10 e 6/kg or a high dose of CD34+ cells of between 10-15 x 10 e 6/kg.

Secondary Objectives:

Determine differences in neutrophil and platelet recovery rates in older patients with myeloma, or patients with amyloidosis undergoing high dose melphalan therapy with either a standard CD34+ cell dose of 4-6 x 10 e 6/kg or a high dose of CD34+ cells of between 10-15 x 10 e 6/kg.
Determine differences in cognitive function and measurements of physical assessment in older patients with myeloma, or patients with amyloidosis undergoing high dose melphalan therapy with either a standard CD34+ cell dose of 4-6 x 10 e 6/kg or a high dose of CD34+ cells of between 10-15 x 10 e 6/kg.
Determine differences in cytokine profiles and their correlation with symptom burden, cognitive function, and physical function in older patients with myeloma, or patients with amyloidosis undergoing high dose high dose melphalan with either a standard CD34+ cell dose of 4-6 x 10 e 6/kg or a high dose of CD34+ cells of between 10-15 x 10 e 6/kg.

Condition	Intervention	Phase
Multiple Myeloma Primary Amyloidosis	Drug: Melphalan Procedure: Stem Cell Infusion Behavioral: Questionnaires Drug: Granulocyte-colony stimulating factor (G-CSF) Procedure: Apheresis	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia transthyretin amyloidosis

MedlinePlus related topics: Amyloidosis Cancer Multiple Myeloma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Granulocyte colony-stimulating factor Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To see how the dose of infused stem cells affects the levels of certain proteins in blood. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
To learn how dose of stem cells received affects quality of life during the weeks after transplant procedure. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Melphalan + Stem Cell Infusion (Standard Dose)	Drug: Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Procedure: Stem Cell Infusion Stem Cell Infusion is Day 0. Arm 1 = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 Arm 2 = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Behavioral: Questionnaires Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. Drug: Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Procedure: Apheresis Collection of stem cells from blood collected either through CVC or from a vein in one arm.
2: Active Comparator Melphalan + Stem Cell Infusion (High Dose)	Drug: Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Procedure: Stem Cell Infusion Stem Cell Infusion is Day 0. Arm 1 = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 Arm 2 = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Behavioral: Questionnaires Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. Drug: Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Procedure: Apheresis Collection of stem cells from blood collected either through CVC or from a vein in one arm.

Arms

Assigned Interventions

1: Active Comparator

Melphalan + Stem Cell Infusion (Standard Dose)

Drug: Melphalan

100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.

Procedure: Stem Cell Infusion

Stem Cell Infusion is Day 0.

Arm 1 = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0

Arm 2 = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0.

Behavioral: Questionnaires

Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.

Drug: Granulocyte-colony stimulating factor (G-CSF)

5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.

Procedure: Apheresis

Collection of stem cells from blood collected either through CVC or from a vein in one arm.

2: Active Comparator

Melphalan + Stem Cell Infusion (High Dose)

Drug: Melphalan

100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.

Procedure: Stem Cell Infusion

Stem Cell Infusion is Day 0.

Arm 1 = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0

Arm 2 = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0.

Behavioral: Questionnaires

Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.

Drug: Granulocyte-colony stimulating factor (G-CSF)

5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.

Procedure: Apheresis

Collection of stem cells from blood collected either through CVC or from a vein in one arm.

Show Detailed Description

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Multiple Myeloma over the age of 60, or with a Charlson Comorbidity Score of greater or equal to 3 in any of the following disease categories: a) Primary Refractory Disease b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) OR
Patients with Primary Amyloidosis.
Zubrod PS of <2.
Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
FEV1, FVC and DLCO >40%. No symptomatic pulmonary disease.
Serum bilirubin <2 X upper limit of normal, SGPT <4 X upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
HIV-negative.
Patient is not pregnant.
Patient or guardian able to sign informed consent.

Exclusion Criteria:

1) Patients unable to perform MDASI or cognitive assessments due to language or cultural barriers.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651937

Contacts

Contact: Sergio A. Giralt, MD

713-794-5745

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sergio A. Giralt, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Sergio A. Giralt, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Sergio A. Giralt, MD/Professor )
Study ID Numbers:	2005-0601
Study First Received:	March 31, 2008
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00651937 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Multiple Myeloma
Primary Amyloidosis
Cytokine Modulation
Melphalan
Alkeran
Transplant Induced Symptoms

Stem Cell Infusion
Autologous stem cell transplant
ASCT
Granulocyte-colony stimulating factor
G-CSF
Apheresis

Study placed in the following topic categories:

Melphalan
Metabolic Diseases
Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Primary Amyloidosis
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Immunosuppressive Agents
Multiple Myeloma
Amyloidosis
Hemorrhagic Disorders
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Alkylating Agents
Metabolic Disorder
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Melphalan
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Alkylating Agents
Neoplasms by Histologic Type
Metabolic Diseases

Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Immunosuppressive Agents
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Amyloidosis
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 11, 2009