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Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

NCT01245673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-04-06

Study results available
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Summary

One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.

Conditions

Interventions

BIOLOGICAL

Prevnar- Pneumococcal Conjugate Vaccine (PCV)

After study enrollment, patients will receive Prevnar- Pneumococcal Conjugate Vaccine (PCV). At Day #14, Day #42, and Day #90, Day #120 and Day #150, patients will receive a booster immunization with Prevnar- Pneumococcal Conjugate Vaccine (PCV).

OTHER

Activated/costimulated autologous T-cell

For all patients, the cells will be expanded ex vivo for up to 12 days and then prepared for infusion \~day 2 post-transplant. The target number of costimulated T-cells for infusion will be \~ 5 x 10e10 T-cells total in 100-500 mL total volume.

DRUG

Revlamid® (Lenalidomide)

At about day 100 post-transplant, after completion of post-transplant immunological assessments and myeloma restaging studies, patients will be eligible to receive low-dose Revlamid® (Lenalidomide) 10 mg/day for maintenance therapy (10 mg/day) until progression of myeloma or development of intolerance.

BIOLOGICAL

MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)

After study enrollment, patients will receive both MAGE-A3/GM-CSF \[+ coinjection of 2mg of Hiltonol®(Poly-ICLC)\]. At Day #14, Day #42, Day #90, Day #120 and Day #150 patients will receive an additional immunization with MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC).

Sponsors & Collaborators

Principal Investigators

  • Aaron Rapoport, M.D. · University of Maryland Greenebaum Cancer Center

  • Ed Stadtmauer, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-10
Primary Completion
2015-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245673 on ClinicalTrials.gov