Phase 2 Completed N=66 Treatment

Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Multiple Myeloma

Source: ClinicalTrials.gov NCT00153920 ↗

Enrolled (actual)

Serious AEs

51.6%

Results posted

Feb 2016

Primary outcomePrimary: Objective Response (OR) Rate — 0.41 proportion of participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response (OR) Rate	0.41	—
SECONDARY Very Good Partial Response (VGPR) Rate	.17	—
SECONDARY Time to Progression (TTP)	17.3	—
SECONDARY Progression-Free Survival (PFS)	17.0	—
SECONDARY Number of Participants With Treatment-Emergent Sensory Neuropathy	41	—
SECONDARY Number of Participants With Treatment-Emergent Neuropathic Pain	8	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00153920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.