Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Revlimid (Lenalidomide), Melphalan, and Dexamethasone (ReMeDex) for Newly Diagnosed Multiple Myeloma Patients Not Undergoing Autologous Transplantation
This study is to determine whether addition of Revlimid to standard therapy will increase overall and complete response rates compared to historical standard frontline therapy and whether this combination treatment has fewer side effects than similar combination induction treatment.
Current multiple myeloma therapies, typically an induction regimen followed by consolidation
therapy with high dose chemotherapy and autologous stem cell rescue (autologous
transplantation), can induce remission but relapse and death are inevitable. A growing body
of literature suggests that consolidation therapy with autologous transplantation does not
confer additional survival benefit and may have increased procedure-related morbidity and
mortality in patients over 65 years old. Autologous transplantation is no longer recommended
as standard care for this population. In addition, certain patients may not be eligible for
autologous transplantation due to co-morbid medical conditions or may elect not to undergo
the procedure for personal reasons.
The historic standard of care for multiple myeloma patients who were not eligible for
autologous transplantation for consolidation was induction therapy with melphalan/
prednisone (MP), often followed by some form of maintenance therapy after achievement of
complete or partial remission. A recent phase 3 study showed that the addition of
thalidomide to MP (MPT) demonstrated higher overall and complete response rates. For
patients who are eligible for autologous transplantation, thalidomide/ dexamethasone (Thal
Dex) induction therapy is considered the standard of care, but a phase 2 study of
lenalidomide (Revlimid)/ dexamethasone (Rev Dex) induction therapy demonstrated higher
overall and complete response rates compared to Thal Dex. In addition, lenalidomide has a
favorable side effect profile compared to thalidomide. Based on these data, we hypothesize
that the combination of Revlimid/ melphalan/ dexamethasone (ReMeDex) induction therapy for
myeloma patients who are not planned for autologous transplantation due to age restriction
or other factors may demonstrate higher overall and/ or complete response rates with fewer
side effects.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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