Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

Browse trials for

• Multiple Myeloma 3,632
• Neoplasms, Plasma Cell 2,306

Keywords

• Advanced Disease
• MAGE-A3 Immunizations with Hiltonol
• Vaccine-Primed Autologous T-Cells
• Lenalidomide Maintenance

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 28 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Study arms

• Experimental
  Prevnar, T Cells, Lenalidomide, MAGE A-3

  All patients will receive a priming immunization with a MAGE-A3/GM-CSF vaccine with adjuvant Hiltonol® (Poly-ICLC) along with the pneumococcal conjugate vaccine/PCV control vaccine about 10 days before a steady-state mononuclear cell apheresis. Patients will then undergo hematopoietic stem cell mobilization. All patients will receive high-dose melphalan followed by hematopoietic stem cells on day 0. On day +2, patients will receive anti-CD3/anti-CD28-costimulated autologous T cells. At days 14, 42, and 90, patients will receive MAGEA3/GM-CSF (+Hiltonol® Poly-ICLC) and PCV booster immunizations followed by restaging studies and immune assessments at day +100. At day 100, after immunizations and restaging, patients will start Revlamid® (Lenalidomide) maintenance therapy followed by 2 additional MAGE-A3 and PCV immunizations at days 120 and 150.

  Biological: Prevnar- Pneumococcal Conjugate Vaccine (PCV) · Other: Activated/costimulated autologous T-cell · Drug: Revlamid® (Lenalidomide) · Biological: MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)

Interventions

• BiologicalPrevnar- 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).

• OtherActivated/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.

• DrugRevlamid® (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.

• BiologicalMAGE-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).

Primary outcomes

1. Primary Myeloma Endpoint

   To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant.

   Time frame: Between day 100 and 180 post transplant

Baseline characteristics

Publications

• Rapoport AP, Aqui NA, Stadtmauer EA, Vogl DT, Xu YY, Kalos M, Cai L, Fang HB, Weiss BM, Badros A, Yanovich S, Akpek G, Tsao P, Cross A, Mann D, Philip S, Kerr N, Brennan A, Zheng Z, Ruehle K, Milliron T, Strome SE, Salazar AM, Levine BL, June CH. Combination immunotherapy after ASCT for multiple myeloma using MAGE-A3/Poly-ICLC immunizations followed by adoptive transfer of vaccine-primed and costimulated autologous T cells. Clin Cancer Res. 2014 Mar 1;20(5):1355-65. doi: 10.1158/1078-0432.CCR-13-2817. Epub 2014 Feb 11. PubMed 24520093 ↗