NCT00153920 · REGISTRY CONDITION SEARCH

Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-06-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response (OR) Rate

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outcome · POSTED

Very Good Partial Response (VGPR) Rate

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Number of Participants With Treatment-Emergent Sensory Neuropathy

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outcome · POSTED

Number of Participants With Treatment-Emergent Neuropathic Pain

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: bortezomib
label
bortezomib
type
EXPERIMENTAL

interventions

arm Group Labels
bortezomib
name
bortezomib
other Names
Velcade
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 66
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Objective Response (OR) Rate
time Frame
Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).

secondary Outcomes

description
Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a \>90% decrease in the difference between involved and uninvolved FLC levels.
measure
Very Good Partial Response (VGPR) Rate
time Frame
Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
description
TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: \>25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); \>25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); \>25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL not attributable to other cause).
measure
Time to Progression (TTP)
time Frame
Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.
description
PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: \>25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); \>25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); \>25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL not attributable to other cause).
measure
Progression-Free Survival (PFS)
time Frame
Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.
description
Number of participants experiencing any grade treatment-emergent sensory neuropathy events based on CTCAEv3 as reported on case report forms.
measure
Number of Participants With Treatment-Emergent Sensory Neuropathy
time Frame
Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
description
Number of participants experiencing any grade treatment-emergent neuropathic pain events based on CTCAEv3 as reported on case report forms.
measure
Number of Participants With Treatment-Emergent Neuropathic Pain
time Frame
Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).

Full study description

brief 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.
detailed Description: 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%.

Source references

references

citation
Richardson 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
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice