A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma
* 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
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
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.
Shaji K. Kumar, MD
United States: Food and Drug Administration
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