Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma

Multiple Myeloma Clinical Trial

— Flu-Mel  

Official title:

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772811
• Other study ID #: C-001
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2008
• Last updated: February 16, 2011
• Start date: July 2001
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Cooperative Study Group A for Hematology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Description:

Treatment plan

• Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.

• Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.

• Melphalan will be administered following the completion of Fludarabine infusion at day -2.

• In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2.

• Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours.

• 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.

• Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed.

• GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients must be 15 years of age or older and 65 years of age or younger

• Patients with CLL, lymphoma, or multiple myeloma will be included in this study

• No prior anti-cancer treatment should be done within 30 days.

• Informed consent should be given.

• Patients should have an HLA-identical or single HLA-locus mismatched donor.

• Karnofsky performance scale should be 50 or over (see Appendix I).

Exclusion Criteria:

• Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible.

• Patients with high serum creatinine level will be excluded.

• Patients should have uncontrolled infection.

• No major anticipated illness or organ failure incompatible with survival from stem cell transplant.

• Serum bilirubin less than or equal to 4.0 mg/dL.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Flu-Mel
Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL. Melphalan will be administered following the completion of Fludarabine infusion at day -2.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)	-To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma.	9years	No
Secondary	include tumor response, incidence of chronic GVHD, and immune reconstitution.	-The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.	9years	No

External Links

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