Safety of Total Therapy III for Newly Diagnosed Multiple Myeloma: Preliminary Analysis of 62 Consecutive Patients.

Abstract

Background: Total therapy III (TT-III) is designed to improve the outcome of newly diagnosed myeloma (MM) patients (pts), especially those presenting with unfavorable cytogenetics. Induction employs 2 cycles of V-DTPACE (Velade™, dexamethasone, thalidomide, cisplatin, adryamycin®, cytoxan®, etoposide) followed by tandem melphalan 200 mg/m2 autologous stem cell transplants (ASCT).Objective: to evaluate the safety outcome of TT-III pts. Materials andMethods: Prospective evaluation of the toxicities occurring throughout treatment in 62 TT-III pts enrolled between February and July 2004.Results: Median age was 59 years (range: 23–74) and 41 pts (66 %) were males. The 1st and 2nd induction cycles were completed in 42 (68%) and 22 (35%) pts respectively, whereas 19 pts (31%) underwent their 1st ASCT. Infections and/or Grades III–IV gastrointestinal tract (GIT) toxicities (NCI Common Toxicity Criteria) were observed throughout treatment in 32 (76%) patients (table). One treatment-related death occurred in an 80 y.o. male with significant pre-existing comorbidities.Conclusion: Gastrointestinal tract toxicities and pneumonia were the most frequent complications following TT-III. Studies are ongoing to identify the risk factors for and interventions to decrease their incidence and severity.Infections and Grade III -IV GIT toxicities throughout TT-IIIToxicityCycle 1 (n=42)Cycle 2 (n=22)1st ASCT (n=19)Pneumonia7 (17%)1 (5%)2 (11%)Bacteremia2 (5%)4 (18%)2 (11%)Septic Shock1 (2%)--C. difficile colitis2 (5%)--Febrile neutropenia2 (5%)2 (10%)5 (26%)Sinusitis2 (5%)--Cellulitis1 (2%)--Mucositis5 (12%)-7 (37%)Nausea/vomiting15 (36%)4 (18%)12 (63%)Diarrhea3 (7%)-4 (21%)