Completed
PHASE3
INTERVENTIONAL
NCT00507416
Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.
Interventions
Name:
Bortezomib
Type:
DRUG
Description:
Bortezomib bolus intravenous (IV) injection
Name:
Dexamethasone
Type:
DRUG
Description:
Dexamethasone for oral administration
Name:
Melphalan
Type:
DRUG
Description:
Melphalan for oral administration
Name:
Prednisone
Type:
DRUG
Description:
Prednisone for oral administration
Name:
Thalidomide
Type:
DRUG
Description:
Thalidomide for oral administration
Primary Outcomes
Measure:
Progression Free Survival (PFS)
TimeFrame:
From randomization until disease progression. Median follow-up time was 43 months.
Description:
PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.
Progressive disease requires 1 of the following:
* Increase of ≥ 25% from nadir in:
* Serum M-component (absolute increase ≥ 0.5 g/dl)
* Urine M-component (absolute increase ≥ 200 mg/24 hours)
* In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl)
* Bone marrow plasma cell percentage (absolute % ≥ 10%)
* Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
* Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease
Trial Information
NCT ID
NCT00507416
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Millennium Pharmaceuticals, Inc.
Last Updated
December 15, 2025