Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

Cell Genesys

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Biological: Therapeutic Cellular Vaccine, GM-CSF Producing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116441

K-0007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• De novo multiple myeloma
• ECOG 0-2
• No serious co-morbid illnesses and adequate organ function
• > 4 weeks from systemic steroids

Exclusion criteria

• No existing secondary malignancies and no history of secondary malignancies in the past 5 years
• No active autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)