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

Cooperative Study Group A for Hematology

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Flu-Mel

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00772811

C-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Flu-Mel

No Intervention group

Description:

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.

Treatment:

Drug: Flu-Mel