Trial Outcomes & Findings for Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma (NCT NCT00635024)

One (1) patient was recruited from May 2008 to September 2008 at Mayo Clinic. This trial was permanently closed in March 2009 due to competing trials.

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

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.

OS was defined as the time from registration to death of any cause.

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

DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.

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)