Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma

NCT01090921

Multiple Myeloma

COMPLETED PHASE2

Preemptive Strike With Bortezomib in Multiple Myeloma Patients

NCT00657553

Multiple Myeloma

TERMINATED PHASE3

An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function

NCT00718640

Multiple Myeloma

TERMINATED PHASE2

Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma

NCT00128921

Multiple Myeloma

TERMINATED PHASE2

Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM

NCT01114282

Multiple Myeloma

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Objective

• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma.

Secondary Objectives

* To evaluate the tolerability and toxicity.
* To evaluate time to progression.
* To assess the frequency and severity of peripheral neuropathy.
* To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy.

Exploratory Objectives

• To perform pharmacogenomic analysis of molecular markers associated with response or non-response.

Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is \>0.95 with a true ORR of 55% and \<0.07 with a true ORR of 35%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bortezomib

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.

Group Type EXPERIMENTAL

bortezomib

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bortezomib

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Velcade

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No