NCT01045460

Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma

Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant. Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant. Study Objectives: Disease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year. Additional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Activated marrow infiltrating lymphocytes	Administered on Days 3 and 4.
BIOLOGICAL	Allogeneic Myeloma Vaccine	Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.
DRUG	Cyclophosphamide	Administered at 2.5 g/m\^2.
BIOLOGICAL	Filgrastim	Administered post cyclophosphamide daily until leukapheresis.
PROCEDURE	Leukapheresis	Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.
DRUG	Melphalan	100 mg/m\^2/day given on Days -2 and -1.
BIOLOGICAL	Autologous stem cell transplant	Infused on Day 0.

Timeline

• Start date: 2010-01-15
• Primary completion: 2014-12-01
• Completion: 2020-06-01
• First posted: 2010-01-11
• Last updated: 2021-04-09
• Results posted: 2019-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study