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Report for Clinical Trial NCT00499577

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. A stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving an infusion of the donor's T cells after the transplant may help destroy any remaining cancer cells. PURPOSE: This phase I/II trial is studying the side effects of stem cell transplant given together with chemotherapy and biological therapy and to see how well it works in treating patients with high-risk or refractory multiple myeloma.

NCT00499577 Multiple Myeloma and Plasma Cell Neoplasm
MeSH:Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma
HPO:Multiple myeloma Plasmacytoma

4 Interventions

Name: CMV pp65 peptide

Description: Given intramuscularly
Type: Biological
Group Labels: 4

Group 1 (HLA-A2 positive) Group 2 Second group 1 Second group 2

Name: hTERT I540/R572Y/D988Y multipeptide vaccine

Description: Given subcutaneously
Type: Biological
Group Labels: 2

Group 1 (HLA-A2 positive) Second group 1

Name: pneumococcal polyvalent vaccine

Description: Given intramuscularly
Type: Biological
Group Labels: 2

Group 1 (HLA-A2 positive) Second group 1

Name: survivin Sur1M2 peptide vaccine

Description: Given subcutaneously
Type: Biological
Group Labels: 2

Group 1 (HLA-A2 positive) Second group 1


Primary Outcomes

Measure: Toxicity at 21 and 28 days post-transplant

Measure: T-cell responses against the hTERT vaccine as measured by tetramer assays at 100 days post-transplant

Measure: Paraprotein levels in the blood or urine and serum free light chain analyses at 60 days and at 6 months post-transplant

Secondary Outcomes

Measure: Cytotoxic T-cell responses against autologous myeloma cell at day 100 post-transplant via chromium-51 release or flow-based assays

Measure: Maximum clinical response

Measure: 1 and 2-year event-free survival

Measure: Overall survival rates

Measure: CD4 and CD8 T-cell responses against cytomegalovirus (CMV) at days 60 and 100 post-transplantation by CFSE dye dilution assays

Measure: Composite binding antibody responses at days 60 and day 100 post-transplant by ELISA

Purpose: Treatment


There are 2 SNPs

SNPs


1 D988Y

- Immunization 1: - Group 1 (HLA-A2 positive): Patients receive the following peptides emulsified in incomplete Freund's adjuvant VG: I) hTERT I540 peptide; ii) hTERT R572Y peptide; iii) hTERT D988Y peptide; iv) survivin Sur1M2 peptide ; and v) CMV control peptide N495 subcutaneously (SC). --- R572Y --- --- D988Y ---


2 R572Y

- Immunization 1: - Group 1 (HLA-A2 positive): Patients receive the following peptides emulsified in incomplete Freund's adjuvant VG: I) hTERT I540 peptide; ii) hTERT R572Y peptide; iii) hTERT D988Y peptide; iv) survivin Sur1M2 peptide ; and v) CMV control peptide N495 subcutaneously (SC). --- R572Y ---



HPO Nodes


HPO: