Mario Fiumanò, Sergio Montanara, Patrizia Zappasodi, Leonardo Campiotti, Enrica Morra, Luciana Barbarano, Luigi Montalbetti, Mario Lazzarino, Daniele Perego, Luciano Isa, Antonio Mazzone, Silvia Mangiacavalli, Alessandro Corso, Alessandro Vismara, L. Uziel, Maria Savarè, Guido Frigerio, Luciano Banfi, and Sergio Fava
Background: In multiple myeloma (MM) patients (pts) undergone high dose therapy, the outcome of the transplant is better if a good response is achieved before the procedure. Therefore, different attempts have been made in intensifying pre-transplant chemotherapy to improve the response. Aim of the study was to evaluate the safety and efficacy of Thal-Dex in improving the response rate after initial VAD therapy. Methods: 61 untreated MM pts aged ≤65 years were addressed to high dose program with a debulking therapy with 3 pulse-VAD cycles followed by Thal-Dex for 3 months at the following schedule: Thal 100 mg/d orally at bed time, continuously for 3 months, Dex 20 mg/d orally on days 1–4 and 14–17 every 28 days. Response at the end of each phase was defined as follows: complete remission (CR), disappearance of serum and urine monoclonal component (MC) by immunofixation and bone marrow plasmocytosis (BMPC) Results: Responses after VAD were evaluable in 60 pts: RC 7%, VGPR 38%, PR 27%, MR 10%, SD 10%, progression 8%. Four pts dropped out after pulse-VAD for progression and in 1 for toxicity. Responses after Thal-Dex in 52 evaluable pts were: RC 12%, VGPR 40%, PR 17%, MR 4%, SD 4%, Progression 23%. Three pts dropped-out during Thal-Dex, 1 for progression and 2 for toxicity. Of note, pts who obtained a scarce response to VAD, namely a MR or SD, showed a higher probability (85% of cases) to have a progression during or after the administration of Thal-Dex. Statistical analysis (Kendall Concordance Coefficient (p Conclusions: The combination thalidomide-dexamethasone after pulse-VAD is not effective in improving response rate, and shows an additional toxicity. Thus it does not seem useful for the intensification before transplant.