Conditions: Hodgkin Disease Lymphoma, Non-Hodgkin Multiple Myeloma Mantle Cell Lymphoma
Keywords: Bone marrow transplantation Hematopoietic stem cell transplantation Hodgkin's disease non-Hodgkin's lymphoma multiple myeloma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation.

Detailed description:
This Phase 2 study will be conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation. Patients will be randomized to receive either LAD 11.25 mg 3 Month treatment or placebo and all patients will be vaccinated with KLH 6 months posttransplant. Patients will be evaluated to determine if the rate of immunologic recovery in the LAD group is enhanced compared with the placebo group.

Arms:
arm 1: Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart. arm 2: Three intramuscular injections of matched placebo administered approximately 3 months apart.

Interventions: intervention 1: Leuprolide acetate depot (LAD) 11.25 mg 3 Month intervention 2: Matched placebo
Intervention descriptions: intervention 1: LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6. intervention 2: Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.

Protocol document: