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Clinical Trial Summary

RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.


Clinical Trial Description

OBJECTIVES:

Primary

* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.

Secondary

- To assess the toxicity and tolerability of this combination in these patients.

- To assess time to disease progression in patients treated with these drugs.

- To assess survival of patients treated with these drugs. OUTLINE: Patients receive anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats every 28 days for 6 courses. Patients then receive melphalan alone as above for another 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00635024
Study type Interventional
Source Mayo Clinic
Contact
Status Terminated
Phase Phase 2
Start date May 2008
Completion date November 2010

See also
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Completed NCT00478075 - Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 1/Phase 2
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Completed NCT00301951 - Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer Phase 1
Completed NCT00937183 - Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma N/A
Terminated NCT00369291 - CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant Phase 1
Completed NCT00049374 - Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 2
Completed NCT00004072 - O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma Phase 2
Completed NCT00003396 - Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer Phase 2
Completed NCT00003398 - Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Phase 4
Completed NCT00003399 - Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Multiple Myeloma Phase 2
Active, not recruiting NCT00003163 - Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers Phase 2
Terminated NCT00005641 - Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation Phase 2
Active, not recruiting NCT00002599 - Combination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma Phase 3