Phase II Study of Intensive "TOTAL THERAPY" for Untreated or Minimally Treated Patients With Multiple Myeloma

NCT00580372 Phase 2 COMPLETED Results posted

This experimental study evaluates the effects of a series of intensive drug regimens as initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4-6 months apart in support of high-dose Melphalan, followed by Interferon treatment indefinitely.

Details

Lead sponsor	University of Arkansas
Phase	Phase 2
Status	COMPLETED
Enrolment	231
Start date	2002-08
Completion	2015-10

Conditions

• Multiple Myeloma

Interventions

• VAD
• High-Dose cyclophosphamide
• Hemopoietic stem cell procurement
• EDAP
• Autologous Hemopoietic Stem Cell Transplant 1
• Autologous Hemopoietic Stem Cell Transplant 2
• Maintenance

Primary outcomes

• Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy — 5 years
  Relapse is defined by the unequivocal objective evidence of recurrent disease such as: myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis \>10% or \>5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for \>2 months.

Countries

United States