Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma
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.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: anti-thymocyte globulin Drug: melphalan||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma|
- Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response [ Time Frame: 4 months ]
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.
Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.
Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.
Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.
- Overall Survival (OS) [ Time Frame: up to 2 years ]OS was defined as the time from registration to death of any cause.
- Progression-free Survival (PFS) [ Time Frame: up to 2 years ]
PFS was defined as the time from registration to progression or death due to any cause.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response in:
- Serum M-component (absolute increase >= 0.5g/dl)
- Urine M-component (absolute increase >= 200mg/24hour
- Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
- Bone marrow plasma cell percentage (absolute increase of >=10%)
- Definite development of new bone lesion or soft tissue plasmacytomas
- Duration of Response (DOR) [ Time Frame: up to 2 years ]DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.
- Number of Participants With Severe Non-hematological Adverse Events [ Time Frame: every month during treatment, up to 12 months ]Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)
|Study Start Date:||May 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Anti-thymocyte Globulin/Melphalan
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Biological: anti-thymocyte globulin
2.5 mg/kgDrug: melphalan
* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635024
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Shaji K. Kumar, MD||Mayo Clinic|