Flu-Mel: Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma

Sponsor

Cooperative Study Group A for Hematology (Other)

Overall Status

Completed

CT.gov ID

NCT00772811

Collaborator

(none)

Enrollment

Location

Arm

113

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Lymphoma Multiple Myeloma	Drug: Flu-Mel	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2001

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Flu-Mel 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.	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. Other Names: Fludara-Alkaran

Arm

Intervention/Treatment

No Intervention: Flu-Mel

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.

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.

Other Names:

Fludara-Alkaran

Outcome Measures

Primary Outcome Measures

To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) [9years]
-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.

Secondary Outcome Measures

include tumor response, incidence of chronic GVHD, and immune reconstitution. [9years]
-The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.