NCT00507442 · REGISTRY CONDITION SEARCH

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients

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

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2013-07-26

The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.

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

Number of Patients With Combined Complete Response and Very Good Partial Response

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outcome · POSTED

Number of Patients With Adverse Events (AEs)

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outcome · POSTED

Number of Patients With Overall Response

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outcome · POSTED

Number of Patients With Stringent Complete Response Rate

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outcome · POSTED

Number of Patients With Complete Response Rate + Near Complete Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Disease Progression

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outcome · POSTED

Time to Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Probability of 1-year Survival

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outcome · POSTED

Overall Survival

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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: * Voluntary written informed consent * Male or female subject 18 years of age or older * A Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group Performance Status score ≤2) * Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage * Diagnosed Multiple myeloma * Subjects must have measurable disease requiring systemic therapy * Subjects must not have been treated previously with any systemic therapy for multiple myeloma * Two weeks must have elapsed since the date of the last radiotherapy treatment * Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women must also agree to ongoing pregnancy testing * Men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential * All subjects must agree to comply with the requirements of the RevAssistSM program Exclusion Criteria: * History of allergy to any of the study medications, their analogues, or excipients in the various formulations * ≥Grade 2 peripheral neuropathy on clinical examination * Myocardial infarction within 6 months prior to enrollment or New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities. * Female subject who is pregnant or breast-feeding * Clinically relevant active infection or serious comorbid medical conditions * Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study. This includes but is not limited to serious medical or psychiatric illness likely to interfere with participation in this clinical study * Active prior malignancy diagnosed or treated within the last 3 years
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)
intervention Names
Drug: VELCADE (bortezomib)
Drug: dexamethasone
Drug: Revlimid (lenalidomide)
label
VDR
type
EXPERIMENTAL
description
VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)
intervention Names
Drug: VELCADE (bortezomib)
Drug: dexamethasone
Drug: cyclophosphamide
Drug: Revlimid (lenalidomide)
label
VDCR
type
EXPERIMENTAL
description
VELCADE (bortezomib), dexamethasone, cyclophosphamide
intervention Names
Drug: VELCADE (bortezomib)
Drug: dexamethasone
Drug: cyclophosphamide
label
VDC
type
EXPERIMENTAL
description
Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide
intervention Names
Drug: VELCADE (bortezomib)
Drug: dexamethasone
Drug: cyclophosphamide
label
VDC-mod
type
EXPERIMENTAL

interventions

arm Group Labels
VDC
VDC-mod
VDCR
VDR
description
bortezomib 1.3 mg/m\^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance).
name
VELCADE (bortezomib)
type
DRUG
arm Group Labels
VDC
VDC-mod
VDCR
VDR
description
dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop
name
dexamethasone
type
DRUG
arm Group Labels
VDC
VDC-mod
VDCR
description
cyclophosphamide 500 mg/m\^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop
name
cyclophosphamide
type
DRUG
arm Group Labels
VDCR
VDR
description
lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm) lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm)
name
Revlimid (lenalidomide)
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 158
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h
measure
Number of Patients With Combined Complete Response and Very Good Partial Response
time Frame
Up to 48 weeks or until disease progression

secondary Outcomes

description
Evaluate the safety and tolerability of the combination therapy
measure
Number of Patients With Adverse Events (AEs)
time Frame
From first dose of study drug through the 30 day post-treatment AE assessment visit
description
Overall Response includes complete response and partial response. Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to \< 200 mg per 24 hour.
measure
Number of Patients With Overall Response
time Frame
Up to 48 weeks or until disease progression
description
Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
measure
Number of Patients With Stringent Complete Response Rate
time Frame
Up to 48 weeks or until disease progression
description
Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.
measure
Number of Patients With Complete Response Rate + Near Complete Response Rate
time Frame
Up to 48 weeks or until disease progression
description
Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
measure
Duration of Response
time Frame
Up to 48 weeks or until disease progression
description
Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
measure
Time to Disease Progression
time Frame
Up to 48 weeks or until disease progression
description
Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.
measure
Time to Response
time Frame
Up to 48 weeks or until disease response
description
Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
measure
Progression-free Survival
time Frame
Up to 48 weeks or until disease progression/death
measure
Probability of 1-year Survival
time Frame
survival probability at 1 year after randomization
description
Overall survival is defined as time from the date of randomization to the date of death
measure
Overall Survival
time Frame
Up to 48 weeks or until death

Full study description

brief Summary: The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.

Source references

references

citation
Kumar S, Flinn I, Richardson PG, Hari P, Callander N, Noga SJ, Stewart AK, Turturro F, Rifkin R, Wolf J, Estevam J, Mulligan G, Shi H, Webb IJ, Rajkumar SV. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012 May 10;119(19):4375-82. doi: 10.1182/blood-2011-11-395749. Epub 2012 Mar 15.
pmid
22422823
type
DERIVED
citation
Kumar SK, Flinn I, Noga SJ, Hari P, Rifkin R, Callander N, Bhandari M, Wolf JL, Gasparetto C, Krishnan A, Grosman D, Glass J, Sahovic EA, Shi H, Webb IJ, Richardson PG, Rajkumar SV. Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study. Leukemia. 2010 Jul;24(7):1350-6. doi: 10.1038/leu.2010.116. Epub 2010 May 27.
pmid
20508619
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice