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Pilot Study of recMAGE-A3 + AS15 ASCI as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Pilot Study of recMAGE-A3 + AS15 ASCI as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Open label, single arm pilot study of recombinant MAGE-A3 protein plus AS15 Adjuvant
(recMAGE-A3 + AS15 ASCI) in 16 patients with symptomatic multiple myeloma, ISS stage 1, 2 or
3, who have completed induction therapy with at least Very Good Partial Response (VGPR) by
International Myeloma Working Group (IMWG) criteria, and who are eligible for high dose
chemotherapy with autologous stem cell transplant (auto-SCT) by standard institutional
criteria. MAGE-A3 tumor antigen expression will be required for study entry. Patients will
receive 8 immunizations over 320 days, with the first immunizations given approximately 6
weeks before auto-SCT, and the rest given post-SCT

Inclusion Criteria:

- Symptomatic multiple myeloma, ISS stage 1, 2 or 3 within 12 months of starting

- Completion of induction therapy with Very Good Partial Response (VGPR), or better, by
International Myeloma Working Group (IMWG) criteria. All induction myeloma therapy
(oral or intravenous, including steroids) must be discontinued for 3 weeks prior to
first immunization. Patients do not need to have measurable disease at the time of
this screening visit.

- Has signed separate informed consent for stem cell mobilization and high dose
chemotherapy/autologous stem cell transplant, and is found to be eligible for stem
cell transplant by standard institutional criteria.

- MAGE-A3 expression determined by IHC must be present in a bone marrow specimen or
plasmacytoma specimen.

- ECOG performance status 0-1 .

- The following laboratory parameters must be within the ranges specified: Neutrophil
count ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 109/L, Platelet count ≥ 50 x 109/L,
Serum creatinine ≤ 2 mg/dL, Serum bilirubin up to 1.5 x ULN for lab, AST and ALT up
to 2 x ULN for lab, Hemoglobin ≥ 8.0 g/dL, INR ≤ 1.5, Partial thromboplastin time ≤
1.5 x ULN for lab unless known history of anti-phospholipid antibody or lupus

- Age ≥ 18 years.

- Able and willing to give valid written informed consent.

Exclusion Criteria:

- Prior treatment with melphalan (Alkeran®), other than 1 cycle (4 days) of oral

- Prior autologous or allogeneic stem cell transplant.

- Previous immunization against MAGE-A3 or other cancer-testis antigens.

- Concurrent malignancies, except for treated non-melanoma skin cancer and cervical
carcinoma in situ.

- Known immunodeficiency, HIV positivity, Hepatitis B or Hepatitis C.

- Known allergy or history of life threatening reaction to G-CSF or GM-CSF.

- History of autoimmune disease (eg., rheumatoid arthritis, lupus), other than
vitiligo, diabetes, or treated thyroiditis, which are allowed.

- History of severe allergic reactions to vaccines or unknown allergens.

- History of myocardial infarction, angina, congestive heart failure, ventricular
tachyarrhythmia, stroke or transient ischemic attack within the past 6 months.

- Other serious illnesses or co-morbid conditions (e.g., serious infections requiring
antibiotics, bleeding disorders, other heart or lung conditions) that in the opinion
of the investigator make the patient inappropriate for high-dose melphalan and
autologous stem cell transplant.

- Pregnancy and breastfeeding.

- Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to first immunization.

- Mental impairment that may compromise the ability to give informed consent and comply
with the requirements of the study.

- Lack of availability for immunological and clinical follow-up assessment.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess safety and tolerability according to the National Cancer Institute CTCAE v4.0

Outcome Description:

Laboratory tests, vital sign measurements, physical exams and patient histories will be performed to detect new abnormalities and deteriorations of any pre-existing conditions

Outcome Time Frame:

Up to 14 months

Safety Issue:


Principal Investigator

Hearn J Cho, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Food and Drug Administration

Study ID:

LGS 2009-005



Start Date:

June 2011

Completion Date:

May 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Mount Sinai School of MedicineNew York, New York  10029
New York University Cancer InstituteNew York, New York  10016