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Dose escalation therapy in previously untreated patients with multiple myeloma following Z‐Dex induction treatment
Author(s) -
Clark Andrew D.,
Douglas Kenneth W.,
Mitchell Lyndsay D.,
McQuaker I. Grant,
Parker Anne N.,
Tansey Patrick J.,
Franklin Ian M.,
Cook Gordon
Publication year - 2002
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1046/j.1365-2141.2002.03519.x
Subject(s) - medicine , melphalan , multiple myeloma , idarubicin , gastroenterology , chemotherapy , dhap , cyclophosphamide , dexamethasone , transplantation , surgery , progressive disease , median follow up , cytarabine , biochemistry , chemistry , enzyme
Summary. A phase I–II study of high‐dose (HD) alkylating agents in newly diagnosed patients with multiple myeloma after maximum response to Z‐Dex (idarubicin, dexamethasone) therapy and DHAP (cisplatin, HD cytosine arabinoside, dexamethasone), stem cell mobilization is reported. Twenty‐six patients, median age 56 years (range 42–66), completed Z‐Dex chemotherapy and peripheral blood stem cells (PBSC) were mobilized with DHAP. Patients then preceded to cyclophosphamide (HD Cy: 6 g/m 2 ) with granulocyte colony‐stimulating factor followed by busulphan–melphalan‐conditioned PBSC autograft. Interferon α was introduced at 3 months post transplant as maintenance therapy. Six patients failed to complete the full protocol. Median time from diagnosis to transplantation was 8 months (range 6–12). Mean CD34 + cell dose collected was 15·8 × 10 6 /kg (CI 11·8, 19·8). Median time from DHAP to HD‐Cy was 6 weeks (range 4–12) and from HD‐Cy to transplant was 8 weeks (range 6–12). The median follow‐up was 36 months (range 6–63). On an intent‐ to‐treat basis, the response rates were three complete response (CR, 12%), 21 partial response (PR, 80%) and two stable disease (SD, 8%) post Z‐Dex, five CR (19%) and 21 PR (81%) post HD‐Cy, and 14 CR (54%) and 12 PR (46%) post transplant. The treatment‐related mortality (TRM) was 4% (1 patient). Median overall survival (OS) and progression‐free survival (PFS) have not been reached; estimated values were 60 and 48 months respectively. The 3‐year OS and PFS were 72% and 62%. Actuarial 5‐year OS and event‐free survival were 49% and 32%. DHAP produces effective PBSC mobilization and sequential HD therapy, including autologous PBSCT, in patients who received Z‐Dex; this offers significant durable disease response rates with acceptable TRM.