CompletedPhase 2

A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma

Austria98 participantsStarted 2007-10

Plain-language summary

The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed symptomatic multiple myeloma who have received no prior treatment and are candidates to receive high-dose therapy and autologous bone marrow/stem cell transplantation.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Calcium elevation (\>11.5 mg/dL or \>2.65 mmol/L)
✓. Renal insufficiency (creatinine \>2 mg/dL or \>177 umol/L)
✓. Anemia (hemoglobin \<10 g/dL \[\<12.5 mmol/L\] or at least 2 mg/dL \[1.25 mmol/L\] below normal)
✓. Bone disease (lytic lesions or osteopenia)
✓. Serum M-protein ≥1 g/dL (≥10 g/L)
✓. Urine M-protein ≥200 mg/24 h
✓. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal

What they're measuring

Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction

Timeframe: all data included in clinical database as of 10 April 2009

Trial details

NCT IDNCT00531453

SponsorMillennium Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-04

Results submitted2010-04-09

View on ClinicalTrials.gov More Multiple Myeloma trials