MDACC Study Summary 2005-0601

Study Summary
No. 2005-0601:.......Blood And Marrow Transplantation; Myeloma......Sergio A. Giralt......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2005-0601

Study 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

Physician

New Patient Referral



Name:	Sergio A. Giralt	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5745 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation Myeloma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Monthly for 3 months and at 6 and 12 months post transplant

Treatment Agents:	Melphalan	Home Care:	NA

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Four weeks for the autologous transplant,

Description/
Intervention:

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.

Study Objectives / Outcomes

Primary Objective
1. 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 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
1. 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.
2. 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.
3. Determine differences in cytokine profiles and their correlation with symptom burden, cognitive function, sensory function, and physical function 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.

Study Status Information



Study Activation / Registration Date:	03/13/2008

IRB Review and Approval Date:	03/13/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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

2) Patients with primary amyloidosis.

3) Zubrod PS of <2.

4) Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

5) FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease.

6) 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.

7) HIV-negative.

8) Patient is not pregnant.

9) Patient or guardian able to sign informed consent.

10) 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.

Links

Registration Number: NCT00651937
Study Information on Clinical Trials Registry (clinicaltrials.gov)