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

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00651937

Purpose

The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

MedlinePlus related topics: Amyloidosis Cancer Multiple Myeloma

Drug Information available for: Melphalan Melphalan hydrochloride Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

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

Primary Outcome Measures:

Mean Symptom Severity Score [ Time Frame: At one week after infusion of high dose chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients receiving a higher stem cell dose who have a lower increase in mean symptom severity score at one week after infusion of high dose chemotherapy as compared to patients receiving the lower stem cell dose [ Time Frame: Baseline to one week post high dose chemotherapy ] [ 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
Active Comparator: Standard Dose 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. Other Name: Alkeran Procedure: Stem Cell Infusion Stem Cell Infusion is Day 0. Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Other Names: Autologous Stem Cell Transplant ASCT Behavioral: Questionnaires Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. Other Names: Survey Automated Phone Interview M.D. Anderson Symptom Inventory MDASI 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.
Active Comparator: High Dose 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. Other Name: Alkeran Procedure: Stem Cell Infusion Stem Cell Infusion is Day 0. Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Other Names: Autologous Stem Cell Transplant ASCT Behavioral: Questionnaires Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires. Other Names: Survey Automated Phone Interview M.D. Anderson Symptom Inventory MDASI 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

Active Comparator: Standard Dose

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.

Other Name: Alkeran

Procedure: Stem Cell Infusion

Stem Cell Infusion is Day 0.

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

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

Other Names:

Autologous Stem Cell Transplant
ASCT

Behavioral: Questionnaires

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

Other Names:

Survey
Automated Phone Interview
M.D. Anderson Symptom Inventory
MDASI

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.

Active Comparator: High Dose

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.

Other Name: Alkeran

Procedure: Stem Cell Infusion

Stem Cell Infusion is Day 0.

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

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

Other Names:

Autologous Stem Cell Transplant
ASCT

Behavioral: Questionnaires

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

Other Names:

Survey
Automated Phone Interview
M.D. Anderson Symptom Inventory
MDASI

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 in any of the following disease categories: a) Primary refractory disease b) Consolidation of a first partial or complete remission. 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.
Have greater than or equal to 10 x 10 e 6 CD34+ cells per kg of autologous stem cells cryopreserved for stem cell transplantation, procured with 5 or fewer apheresis collections.

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: Nina Shah, MD

713-794-5745

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Nina Shah, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00651937 History of Changes
Other Study ID Numbers:	2005-0601
Study First Received:	March 31, 2008
Last Updated:	March 7, 2012
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

Additional relevant MeSH terms:

Amyloidosis
Multiple Myeloma
Neoplasms, Plasma Cell
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

Immunoproliferative Disorders
Immune System Diseases
Melphalan
Lenograstim
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 22, 2012