Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m\^2 IV over 30 minutes daily on Days -2 and -1.

On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation.

Apheresis

Stem Cell Transplantation

100 mg/m\^2 IV over 30 minutes daily on Days -2 and -1

Yago Nieto, MD, PHD

The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.

A transplant of one's own bone marrow stem cells is part of a standard treatment for MM. Because MM comes from the bone marrow, stem-cell products from the bone marrow can have tumor cells mixed in them when they are transplanted. This may cause the disease to return after transplant. This study will learn about a method of cleaning, or "purging," the MM tumor cells from the stem cells by using the bone marrow of a relative.

Study Drugs:

Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be given G-CSF twice a day through a needle under the skin on Days 1-5 to move stem cells from out of the bone marrow and into the blood.

You will receive melphalan through a needle in your vein over 30 minutes each time on the 2 days directly before you receive the stem cell transplant.

Stem Cell Collection, Purging, and Transplantation:

On Day 5, stem cell collection will begin. You will have a central venous catheter (CVC - a sterile, flexible tube) placed into a vein in your chest while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.

Blood will be removed from your body through the CVC and passed through a machine that separates stem cells from the other cells. The stem cells will be frozen for storage, and the blood will be returned to your body. This 3-hour process is called apheresis. This process will be done 1 time a day for 1-6 days, or until enough stem cells are collected.

Your stem cells will be placed in a sterile container, where they will grow and multiply with donated stem cells from a relative. If there are enough cells after 2 weeks, the cells will be transplanted back into the body. If there are not enough cells after the 2 weeks of growing with the donor's stem cells, they will be combined with a sample that was set aside at your initial collection and then transplanted back into the body.

Study Visits:

One (1), 2, and 6 months after the transplant, blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the disease.

Six (6) months after the transplant, you will also have a bone marrow aspirate/biopsy to check the status of the disease.

Length of Study:

You will remain on study until 12 months after the transplant. You will be taken off study if the disease gets worse or needs further treatment.

End-of-Treatment Visit:

Twelve (12) months after the transplant, you will have your end-of-treatment visit. At this time, the following tests and procedures will be performed:

* Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the disease.
* You will have a bone marrow aspirate/biopsy.
* You will have x-rays taken of your bones.

This is an investigational study. Melphalan is FDA approved and commercially available for the treatment of MM. While receiving a stem-cell transplant is standard treatment for MM, cleaning (purging) the stem-cell product is investigational.

Up to 25 recipients will take part in this study. All will be enrolled at M. D. Anderson

Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts

M.D. Anderson Cancer Center

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Lymphatic Diseases

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Fludarabine

Fludarabine phosphate

Thymoglobulin

Antilymphocyte Serum

Antimetabolites

Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m\^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

25 mg/m\^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.

70 mg/m\^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.

Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.

Allogeneic Transplant

2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

Chitra M. Hosing, MD

The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.

You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications.

The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given.

Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant.

You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment.

This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson.

Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma

Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)

Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.

OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days.

Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

Fludarabine + Melphalan With PBPC

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Chitra M. Hosing, Professor, Stem Cell Transplantation

Complete Response (CR) Converted Post Transplant

CR Prior to Transplant

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)

Baseline to disease progression, followed up to 5 years post transplant (assess at 100 days, every 3 months for 2 years, then once a year for at least 3 years)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts	NCT00968396	Multiple Myelom...	Apheresis Stem Cell Trans... Melphalan	18 Years - 75 Years	M.D. Anderson Cancer Center
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma	NCT00506129	Lymphoma Disorder Relate...	Fludarabine Melphalan Allogeneic Tran... Thymoglobulin	- 70 Years	M.D. Anderson Cancer Center
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma	NCT00506129	Lymphoma Disorder Relate...	Fludarabine Melphalan Allogeneic Tran... Thymoglobulin	- 70 Years	M.D. Anderson Cancer Center
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma	NCT00506129	Lymphoma Disorder Relate...	Fludarabine Melphalan Allogeneic Tran... Thymoglobulin	- 70 Years	M.D. Anderson Cancer Center
Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts	NCT00968396	Multiple Myelom...	Apheresis Stem Cell Trans... Melphalan	18 Years - 75 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pbpc

Every month we try and update this database with for pbpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pbpc

Every month we try and update this database with for pbpc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pbpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.