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A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade

This is an Open-Label (all people know the identity of the intervention), non-randomized,
multicenter (when more than one hospital or medical school team work on a medical research
study), single arm study to evaluate the safety and efficacy of bortezomib in
participants with multiple myeloma (cancer of the types of cells normally found in bone
marrow) who have previously responded to a bortezomib based therapy. Participants will be
non-randomly assigned to single group bortezomib. Participants will be treated with
bortezomib alone or in combination with another drug (dexamethasone). Bortezomib will be
given intravenously (i.v. [into a vein]) twice Weekly, on Days 1, 4, 8 and 11 of each cycle
followed by a 10-day (Days 12 to 21) rest period. The total duration of treatment period
will be 8 cycles, each lasting 3 weeks. The initial bortezomib dose is the last tolerated
dose (1.0 or 1.3 milligram per metersquare [mg/ m^2] on the previous bortezomib-based
treatment. Participants who start the study on a dose of 1.0 mg/m^2 bortezomib and tolerate
the dose well could have their dose escalated to 1.3 mg/m^2. Doses above 1.3 mg/m^2 are not
allowed. A complete cycle comprises 4 doses of bortezomib. Dexamethasone will be first
introduced in Cycles 1 to 5 (i.e.dexamethasone will not be introduced for the first time in
Cycles 6 to 8). The median total dose of dexamethasone received per cycle ranges from 120 mg
(cycle 7) to 160 mg (cycles 1 to 6 and 8). Efficacy will be primarily assessed by
determining Best Confirmed Response according to the European Group for Blood and Marrow
Transplantation (EBMT) criteria. Participant's safety will be monitored throughout the

Inclusion Criteria:

- Participant was previously diagnosed with multiple myeloma based on standard criteria
and had measurable disease. Measurable disease for secretory multiple myeloma was
defined as any quantifiable serum M-protein value (generally, but not exclusively,
greater than (>) 1 gram per deciliter (g/dL) immunoglobulin (Ig) G Myeloma protein
(M-protein) and >0.5 g/dL Ig A) or urine light-chain excretion of equal to (=) or
>200 milligram (mg)/24 hour

- Participant previously tolerated 1.0 or 1.3 mg/metersquare (m^2) bortezomib alone or
in combination with other agents and had complete response (CR) or partial response
(PR) upon completion of bortezomib therapy

- It had been greater than or equal to (>=) 6 months since the participant's last
bortezomibdose and the participant had progressive disease (PD) if prior response to
bortezomib was PR or the participant had relapsed from CR

- Participant had a life expectancy >3 months

- If female, the participant was either postmenopausal or surgically sterilized or
willing to use an acceptable method of birth control from screening through at least
30 days after completion of the last cycle

Exclusion Criteria:

- Participant had received chemotherapy, radiotherapy, antibody, immunotherapy, or
experimental therapy to treat multiple myeloma since their last dose of bortezomib.
Note: participants could have received localized palliative radiotherapy for
complications due to osteolytic bone lesions. Participants could have received
steroids (dexamethasone or equivalent) or thalidomide or interferon as maintenance
therapy since their last dose of bortezomib according to local standard of care. In
addition, participants could have received a cumulative dose of up to 160 mg
dexamethasone or equivalent as emergency therapy within 4 weeks prior to enrolment.
Participants could have received high dose therapy/stem cell transplantation after
induction regimen containing bortezomib, but only if PR or CR was observed during
bortezomib containing induction therapy

- Participant had uncontrolled or severe cardiovascular disease, including myocardial
infarction within 6 months of enrolment or had New York Heart Association Class III
or IV heart failure, uncontrolled angina, clinically significant pericardial disease,
severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities

- Participant had poorly controlled hypertension, diabetes mellitus, or other serious
medical or psychiatric illness that could potentially interfere with the completion
of treatment according to the protocol

- Participant had another malignancy within the past 5 years. Exceptions were made for
the following if they were treated and not active: basal cell or non-metastatic
squamous cell carcinoma of the skin, cervical carcinoma in situ or International
Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix

- Patient has an uncontrolled or severe cardiovascular disease, within 6 months of

- Female participant was pregnant or breast feeding. Confirmation that the participant
was not pregnant was to be established by a negative beta human chorionic
gonadotropin pregnancy test result obtained during the Screening period. Pregnancy
testing was not required for post menopausal or surgically sterilized women.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Confirmed Response to Bortezomib Re-Treatment

Outcome Description:

Number of participants with best confirmed response to bortezomib Re-Treatment will be assessed by the European Group for Blood and Marrow Transplantation (EBMT) criteria. Best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. The ordering of possible responses are Complete Response (CR), Partial Response (PR), Minimal Response (MR), No Change (NC) and Progressive Disease (PD)/relapse from CR. CR is the best response and the poorest response is PD or relapse from CR.

Outcome Time Frame:

Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)

Safety Issue:


Principal Investigator

Janssen-Cilag International NV Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag International NV


Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:




Start Date:

June 2006

Completion Date:

January 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Bortezomib
  • Dexamethasone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell