TABLE I.
Summary of the 12 myeloma trials meeting the inclusion criteria
| Study | Patient characteristics | Treatment | Evaluable [n (%)] |
|---|---|---|---|
| Relapsed/refractory myeloma — phase iii rcts | |||
| Richardson et al. 20042 (apex) | Relapsed mm (1–3 prior regimens); dexamethasone-refractory disease excluded | Bortezomib 1.3 mg/m2 vs.
Dexamethasone 40 mg |
315 (95%)
312 (93%) |
| Relapsed/refractory myeloma — phase ii extension study trials | |||
| Jagannath et al. 20043 (crest) | mm in relapse or refractory to first-line therapy, including asct | Bortezomib 1.0 mg/m2 Bortezomib + dexamethasone 20 mg vs. Bortezomib 1.3 mg/m2 Bortezomib + dexamethasone 20 mg |
27 (96%)
16 26 (100%) 12 |
| Richardson et al. 20034 (summit) | Relapsed mm and refractory to salvage chemotherapy | Bortezomib 1.3 mg/m2 Bortezomib + dexamethasone 20 mg |
193 (96%)
74 |
| Relapsed/refractory myeloma — combination therapy and dose escalation | |||
| Berenson et al. 20045 (abstract) | Previously treated refractory/relapsed mm | Bortezomib 0.7 mg/m2a, plus melphalan 0.025–0.25 mg/kg dose cohorts | 24 (92%) |
| Hollmig et al. 20046 (abstract) | High-risk, advanced mm | Bortezomib 1.0 or 1.3 mg/m2, plus melphalan 100–250 mg/m2, plus asct | 27 (73%) |
| Zangari et al. 20047 (abstract) | Refractory mm after transplant and salvage treatmentb | Bortezomib 1.0 mg/m2c, plus daily thalidomide 50–200 mg dose cohortsd | 79 |
| Orlowski 20038 (abstract) | Refractory mm | Bortezomib 0.9–1.5 mg/m2, plus pegylated doxorubicin 30 mg/m2 | 22 (92%) |
| Newly diagnosed myeloma — phase ii monotherapy | |||
| Richardson et al. 20049 (abstract) | Previously untreated, symptomatic mm | Bortezomib 1.3 mg/m2 | 22 (79%) |
| Newly diagnosed myeloma — combination therapy and dose escalation | |||
| Wang et al. 200410 (abstract) | Newly diagnosed mm | Bortezomib 1.0–1.9 mg/m2, plus thalidomide 100–200 mg daily, plus dexamethasone 20 mg/m2 | 25 (100%) |
| Newly diagnosed myeloma — combination therapy before asct | |||
| Jagannath et al. 200411 (abstract) | Newly diagnosed mm patients; asct at physician discretion | Bortezomib 1.3 mg/m2 Bortezomib + dexamethasone 20 mg |
23 (61%)
14 |
| Barlogie et al. 200412 (abstract) | Newly diagnosed mm | Bortezomib, thalidomide, dexamethasone, plus pace, plus peripheral blood stem cell collection, melphalan-based asct | 57 (100%) |
In the absence of dose-limiting toxicity, bortezomib increased to 1.0 mg/m2.
One patient did not receive a transplant as per a previous report of this trial10.
Bortezomib increased to 1.3 mg/m2 in absence of grade 3 neurotoxicity.
To-date accrual done to bortezomib 1.3 mg plus thalidomide 150 mg.
rct = randomized controlled trial; apex = Assessment of Proteasome Inhibition for Extending Remissions study; mm = multiple myeloma; crest = Clinical Response and Efficacy Study (of Bortezomib in the Treatment of Relapsing Multiple Myeloma); asct = autologous stem-cell transplantation; summit = Study of Uncontrolled Multiple Myeloma Managed with Proteasome Inhibition Therapy; pace = 4-day infusion of cisplatin 10 mg/m2, doxorubicin 10 mg/m2, cyclophosphamide 400 mg/m2, and etoposide 40 mg/m2.