Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment recmage-a3 protein plus as15 adjuvant
Phase phase 1
Sponsor Ludwig Institute for Cancer Research
Collaborator GlaxoSmithKline
Start date June 2011
End date July 2014
Trial size 16 participants
Trial identifier NCT01380145, 10-051, 10-216, LGS 2009-005

Summary

This study seeks to assess the safety and immunogenicity of recombinant MAGE-A3 protein plus AS15 Adjuvant in patients with symptomatic multiple myeloma, who have completed induction therapy with at least Very Good Partial Response and who are eligible for high dose chemotherapy with autologous stem cell transplant.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
recmage-a3 protein plus as15 adjuvant ASCI
Eight intramuscular immunizations with 300 mcg recMAGE-A3 Protein plus AS15 Adjuvant

Primary Outcomes

Measure
Assess safety and tolerability according to the National Cancer Institute CTCAE v4.0
time frame: Up to 14 months

Secondary Outcomes

Measure
Induction or augmentation of MAGE-A3-specific humoral immunity
time frame: Baseline. Day 45, 24 & 10 prior to Stem Cell Transplantation. Day 31, 73 194, 284 & 374 after Stem Cell Transplantation
Assess tumor response and disease progression in accordance with the established International Myeloma Working Group (IMWG) criteria
time frame: Up to 14 months
Induction or augmentation of MAGE-A3-specific cellular immunity
time frame: Baseline. Day 45, 24 & 10 prior to Stem Cell Transplantation. Day 31, 73 194, 284 & 374 after Stem Cell Transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Symptomatic multiple myeloma, ISS stage 1, 2 or 3 within 12 months of starting therapy. - 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 anticoagulant) - 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 melphalan. - 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.

Additional Information

Official title Pilot Study of recMAGE-A3 + AS15 ASCI as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Principal investigator Adam D Cohen, MD
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Ludwig Institute for Cancer Research.