CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
recMAGE-A3 Protein + AS15 Adjuvantbiological
Likely dose
recMAGE-A3 Protein + AS15 Adjuvant 300 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01380145
NCT01380145Phase 1Completed
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Pilot Study of recMAGE-A3 + AS15 ASCI as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Ludwig Institute for Cancer Research·interventional·Posted Jun 27, 2011·Updated Oct 25, 2022

In Brief

A Phase 1 clinical trial evaluating recMAGE-A3 Protein + AS15 Adjuvant for Multiple Myeloma. Completed, enrolled 13 participants across 4 sites.

Detailed Summary

This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to determine the safety and tolerability of immunizations when administered prior to stem cell mobilization and multiple times after stem cell reinfusion. Secondary objectives were to assess the humoral and cellular immunogenicity and clinical outcomes of immunization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsGlaxoSmithKline, MOUNT SINAI HOSPITAL, NYU Langone Health, Fox Chase Cancer Center, Memorial Sloan Kettering Cancer Center

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartSep 1, 2011
Primary CompletionJul 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.0 years ago

Interventions

recMAGE-A3 Protein + AS15 Adjuvantbiological

recMAGE-A3 + AS15 was administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.