Review of M-Dex treatment
| Study and reference(s) . | No. of patients . | Recruitment dates . | Median follow-up . | Patient description . | Median age, y . | M-Dex dosage . | Median no. of cycles . | Toxicity CTC grade > 3, % of patients . | HR/CR/OR, % (intention to treat) . | Median OS, mo/no. death within 3 mo, % of patients . |
|---|---|---|---|---|---|---|---|---|---|---|
| Palladini7,8 | 46 | 1999-2002 | 20 mo (living patients) | Untreated; not eligible for HDM | 62 | M: 0.22 mg/kg; Dex: 40 mg | 4 | 11 | 67/33/48 | Not reached/4% |
| Jaccard9 | 50 | 2000-2005 | n.a. | 48 patients untreated; eligible for HDM | 59 | M: 10 mg/m2; Dex: 40 mg | 12 | 15 | 52/24/34 | 57/10% |
| Lebovic30 | 40 | 2004-2007 | n.a. | Untreated; not eligible for HDM | 67 | M: 0.22 mg/kg;* Dex: 20 mg/m2 | 4 | n.a. | 58/13/n.a | 10.5†/23% |
| Current study | 61 | 2004-2007 | 27 months | Untreated; not eligible for HDM | 65 | M: 16 mg/m2, day 1 (IV)‡; Dex: 20-40 mg | 4 | 33 | 44/11/25 | 17.5/28% |
| Study and reference(s) . | No. of patients . | Recruitment dates . | Median follow-up . | Patient description . | Median age, y . | M-Dex dosage . | Median no. of cycles . | Toxicity CTC grade > 3, % of patients . | HR/CR/OR, % (intention to treat) . | Median OS, mo/no. death within 3 mo, % of patients . |
|---|---|---|---|---|---|---|---|---|---|---|
| Palladini7,8 | 46 | 1999-2002 | 20 mo (living patients) | Untreated; not eligible for HDM | 62 | M: 0.22 mg/kg; Dex: 40 mg | 4 | 11 | 67/33/48 | Not reached/4% |
| Jaccard9 | 50 | 2000-2005 | n.a. | 48 patients untreated; eligible for HDM | 59 | M: 10 mg/m2; Dex: 40 mg | 12 | 15 | 52/24/34 | 57/10% |
| Lebovic30 | 40 | 2004-2007 | n.a. | Untreated; not eligible for HDM | 67 | M: 0.22 mg/kg;* Dex: 20 mg/m2 | 4 | n.a. | 58/13/n.a | 10.5†/23% |
| Current study | 61 | 2004-2007 | 27 months | Untreated; not eligible for HDM | 65 | M: 16 mg/m2, day 1 (IV)‡; Dex: 20-40 mg | 4 | 33 | 44/11/25 | 17.5/28% |
A 28-day cycle was used in all M-Dex studies. Dex was given on days 1-4. All studies used oral melphalan (day 1-4) except ours. Different HR criteria/HDM exclusion criteria as follows: Palladini et al7,8 : HR without FLC assessment more than 2 organs involved, severe cardiac involvement, creatinine greater than 2 mg/dL, abnormal respiratory function test, older than 65 years of age. Jaccard et al9 : HR only in n = 19 patients with FLC assessment/older than 70 years of age, Eastern Cooperative Oncology Group greater than 2. Lebovic et al30 : HR with FLC assessment/older than 60 years of age, more than 3 organs involved, advanced cardiac disease. Current study: HR with FLC assessment/older than 70 years of age, greater than NYHA stage II, PS greater than 2, systolic blood pressure less than 90 mm Hg, symptomatic pleural effusions, factor X deficiency less than 10%.
CR indicates complete remission; CTC, Common Terminology Criteria; FLC, free light chain assay; HDM, high-dose melphalan; HR, hematologic remission; IV, intravenous; M-Dex, melphalan and dexamethasone; mo, months; OR, organ response; OS, overall survival; and PS, performance status.
Creatinine greater than 2: M reduced to 0.18 mg/kg, patients older than 70 years, 50% dosage.
Since diagnosis.
Adapted to creatinine clearance.