NCT00834665

Brief Summary

The purpose of this study is:

  1. 1.To evaluate the safety of activated T cell infusions and immunization with hTERT multi-peptide vaccine in the post-transplant setting and whether the combination can delay hematopoietic recovery or induce other autoimmune events.
  2. 2.To determine whether the strategy of infusing vaccine-primed T-cells early after transplant in conjunction with post-transplant boosters leads to the induction of cellular immune responses to hTERT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

11 years

First QC Date

January 3, 2008

Last Update Submit

October 21, 2019

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Primary toxicity endpoint

    Incidence of delayed hematopoietic recovery and the incidence of Grade 3 or greater autoimmune events

    2 yrs

Study Arms (2)

hTERT/GM-CSF+PCV, T cell infusion

EXPERIMENTAL

ARM A = hTERT/GM-CSF+PCV, T cell infusion

Biological: hTERT vaccine, GM-CSF, PCV, T cell infusion

GM-CSF+PCV, T cell infusion,GM-CSF+PVC

EXPERIMENTAL

ARM B GM-CSF+PCV, T cell infusion,GM-CSF+PVC

Biological: GM-CSF, PCV, T cell infusion

Interventions

hTERT vaccine, GM-CSF, PCV, T cell infusionBIOLOGICAL

hTERT vaccine (multi-peptide vaccine), Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Prevnar-Pneumococcal Conjugate vaccine (PCV), T cell infusion

hTERT/GM-CSF+PCV, T cell infusion
GM-CSF, PCV, T cell infusionBIOLOGICAL

Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Prevnar-Pneumococcal Conjugate vaccine (PCV), T cell infusion

GM-CSF+PCV, T cell infusion,GM-CSF+PVC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Subjects who meet ANY of the following criteria cannot be enrolled in the study:
  • Pregnant or nursing females
  • HIV, HTLV-1/2 seropositivity
  • Known history of myelodysplasia
  • Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
  • Active Hepatitis B
  • Prior autotransplant or allogeneic transplant
  • More than 4 distinct, prior courses of therapy for myeloma
  • History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
  • Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
  • Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which might increase the risks of participating in the study
  • Active bacterial, viral or fungal infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Greenbaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Rapoport AP, Aqui NA, Stadtmauer EA, Vogl DT, Fang HB, Cai L, Janofsky S, Chew A, Storek J, Akpek G, Badros A, Yanovich S, Tan MT, Veloso E, Pasetti MF, Cross A, Philip S, Murphy H, Bhagat R, Zheng Z, Milliron T, Cotte J, Cannon A, Levine BL, Vonderheide RH, June CH. Combination immunotherapy using adoptive T-cell transfer and tumor antigen vaccination on the basis of hTERT and survivin after ASCT for myeloma. Blood. 2011 Jan 20;117(3):788-97. doi: 10.1182/blood-2010-08-299396. Epub 2010 Oct 28.

    PMID: 21030558BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Carl H June, MD

    University of Pennsylvania

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

February 3, 2009

Study Start

December 1, 2006

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)