NCT00635024

Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma

A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	2.5 mg/kg
DRUG	melphalan	16 mg/m\^2

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-07-01
• Completion: 2010-11-01
• First posted: 2008-03-13
• Last updated: 2017-02-10
• Results posted: 2010-10-18

Locations

1 site across 1 country: United States