Clinical trial · Interventional
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
NCT00153920CI-TRIAL-00039029completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bortezomib
- description
- Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- Objective Response (OR) Rate
- timeFrame
- Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
- description
- Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; \<5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma based upon standard criteria * Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1 g/dl and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours. * Karnofsky performance status of \> 60 * Hemoglobin \> 8.0 g/dL * AST (SGOT) \< 3 x ULN * ALT \< 3 x ULN * Total bilirubin \< 2 x ULN * Is infertile or is practicing an adequate form of contraception * 18 years of age or older Exclusion Criteria: * Prior treatment with systemic chemotherapy * Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes * Plasma cell leukemia * Calculated or measured creatinine clearance \< 30 mL/minute within 14 days of enrollment * Grade 2 or greater peripheral neuropathy * Hypersensitivity to bortezomib, boron or mannitol * Severe hypercalcemia * HIV positive * Known active hepatitis B or C * New York Hospital Association Class III or IV heart failure * Second malignancy requiring concurrent treatment * Other serious medical or psychiatric illness * Pregnant women * Dialysis dependent patients
References
Publications (1)
- RESULTRichardson PG, Xie W, Mitsiades C, Chanan-Khan AA, Lonial S, Hassoun H, Avigan DE, Oaklander AL, Kuter DJ, Wen PY, Kesari S, Briemberg HR, Schlossman RL, Munshi NC, Heffner LT, Doss D, Esseltine DL, Weller E, Anderson KC, Amato AA. Single-agent bortezomib in previously untreated multiple myeloma: efficacy, characterization of peripheral neuropathy, and molecular correlations with response and neuropathy. J Clin Oncol. 2009 Jul 20;27(21):3518-25. doi: 10.1200/JCO.2008.18.3087. Epub 2009 Jun 15. PMID 19528374