(BMT CTN Protocol 0702) A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma

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Title (BMT CTN Protocol 0702) A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma
Contact DC
Principal Investigator Hong Liu MD
Study Number 176610
Phase3
Summary

The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib, and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM).  Lenalidomide will be used as maintenance therapy for three years in all arms.  The primary objective of the randomized trial is to compare three-year progression-free survival (PFS) between the three treatment arms as a pairwise comparison.

Eligibility
  • Patients who are 70 years of age or younger at the time of enrollment.
  • Karnofsky performance score greater than 70.
  • Symptomatic MM requiring treatment.
  • Have received at least two cycles of systemic therapy and who are within 2-12 months of initiation of the initial therapy.
  • Patients must have adequate autologous graft 4 x 106 CD34+ cells/kg patient weight.

 

For more information about the clinical study go to Clinicaltrial.Gov