NCT00505895 · REGISTRY CONDITION SEARCH

FM 140 vs FM100 Study in Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-10-17

The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome

Number of Participants With Successful Engraftment at Day 100

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outcome

Acute Grade II-IV Graft Versus Host Disease (GVHD)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory considered poor candidate for autologous transplant, b) Remission Consolidation in patients with Chromosome 13 abnormalities or plasma cell leukemia, c) All relapsing patients. 2. Age up to 70 years. 3. Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C, DRB1 and DQ) by molecular techniques. 4. Zubrod Performance Score (PS)\<2. 5. Life expectancy is not severely limited by concomitant illness. Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic cardiac disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) \>40%. 6. Patient and donor or guardian willing and able to sign informed consent. Exclusion Criteria: 1\) Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
intervention Names
Drug: Melphalan
Drug: Fludarabine
Procedure: Stem Cell Infusion
Drug: Rituximab
label
Fludarabine + Melphalan + Stem Cell Infusion
type
EXPERIMENTAL
description
Fludarabine 30 mg/m\^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 intravenous infused starting on day -5.
intervention Names
Drug: Melphalan
Drug: Fludarabine
Procedure: Stem Cell Infusion
Drug: Rituximab
label
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
type
EXPERIMENTAL

interventions

arm Group Labels
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine + Melphalan + Stem Cell Infusion
description
Arm 1 = 140 mg/m\^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m\^2 intravenous over 20 Minutes on Day -1.
name
Melphalan
other Names
Alkeran
type
DRUG
arm Group Labels
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine + Melphalan + Stem Cell Infusion
description
30 mg/m\^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
name
Fludarabine
other Names
Fludara
Fludarabine Phosphate
type
DRUG
arm Group Labels
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine + Melphalan + Stem Cell Infusion
description
Stem Cell Infusion on Day 0.
name
Stem Cell Infusion
other Names
Allogeneic Peripheral Blood Stem Cell Transfusion
APBSCT
Bone Marrow Transplantation
BMT
type
PROCEDURE
arm Group Labels
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine + Melphalan + Stem Cell Infusion
description
375 mg/m\^2 intravenous on Day -5, +2 +9 and +16.
name
Rituximab
other Names
Rituxan
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 52
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Number of Participants With Successful Engraftment at Day 100
time Frame
Day 100

secondary Outcomes

description
Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.
measure
Acute Grade II-IV Graft Versus Host Disease (GVHD)
time Frame
GVHD grading weekly during first 100 days; Annual examinations for nine year study period

Full study description

brief Summary: The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.
detailed Description: Fludarabine is a chemotherapy drug that is used in various diseases. Melphalan is a chemotherapy drug that has been widely used in the treatment of multiple myeloma for many years. Before beginning therapy, patients will have a complete work-up. This includes a bone marrow aspiration and biopsy, bone survey, blood tests, and tests to check the heart and lung function. All patients will receive tacrolimus and methotrexate to prevent graft-versus-host disease. Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance that a patient will be in either group. Patients in the first group will receive fludarabine through the vein every day for four days. On the fourth day, patients will receive a dose of melphalan through the vein over 20 minutes. On the following day, patients will receive the donor cells as an infusion through their catheter. Patients in the second group will receive fludarabine through the vein every day for four days. Patients in this group will receive a lower dose of melphalan through the vein over 20 minutes. After the last dose of fludarabine, patients will receive the donor cells as an infusion through their catheter the next day. If you have an unrelated or a mismatched donor, you will receive the drug ATG (Thymoglobulin) by vein over 6 hours on Days -3, -2, and -1 (the 3 days before the transplant), to prevent graft versus host disease (GVHD) and to help engraftment. Patients in both group will be receiving the monoclonal antibody called rituximab weekly starting on the fifth day before the stem cell transplant for a total of 4 doses. Patients will remain in the hospital for about 4-6 weeks and in Houston Medical Center area at least 100 days after transplantation. Patients whose disease gets worse will be taken off study. These patients will continue to be followed for survival. This is an investigational study. All of the drugs used in this study are commercially available. The FDA has approved melphalan for the treatment of myeloma. Fludarabine is not approved for the treatment of myeloma but has been used for years as a way to prepare patients for transplant. About 30 to 60 patients will take part in this study. About 45 patients will be enrolled at M. D. Anderson.

Source references