An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma

NCT00431769 | Completed Phase 2

• 3 other identifiers: CR01051926866138MMY20362005-005819-26
• Study Type: interventional
• Target: 130
• Locations: 8 countries
• Sites: 38

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Bortezomib; Dexamethasone; VELCADE

Outcome Measures

Primary Outcomes (1)

• Best Confirmed Response to Bortezomib Re-Treatment

  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.

  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)

Secondary Outcomes (4)

• Participants With Percent Change in Baseline Serum Monoclonal Protein (M-protein) Best Confirmed Response Category

  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)

• Participants with Percent Change in Baseline Urine Monoclonal Protein (M-protein) Best Confirmed Response Category

  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)

• Duration of Best Confirmed Response (DOR)

  Day 1 Cycle 1 up to last follow-up visit (8 weeks until PD)

• Time to Progression (TTP) for Best Confirmed Response

  (Day 1 Cycle 1 up to last follow-up visit date (8 weeks until PD)

Study Arms (1)

Bortezomib

EXPERIMENTAL

Drug: Bortezomib

Interventions

Bortezomib DRUG

Bortezomib will be given intravenously (into a vein) twice weekly, on Days 1, 4, 8 and 11 and then a 10-day (Days 12 to 21) rest period, of each 3-week cycle for up to a total of 8 cycles. The initial bortezomib dose is 1.0 or 1.3 milligram per meter square (mg/m\^2) depending on the previous bortezomib-based treatment, up to a maximum dose of 1.3 mg/m\^2. Participants will receive bortezomib in combination with or without dexamethasone, in accordance with the standard of care. The median total dose of dexamethasone per cycle ranges from 120 mg (Cycle 7) to 160 mg (Cycles 1 to 6 and 8).

Bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 enrolment
• 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.

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (38)

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Graz, Austria

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Oberpullendorf, Austria

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Vienna, Austria

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Antwerp, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Roeselare, Belgium

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Dijon, France

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Limousis, France

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Marseille, France

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Nantes, France

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Paris, France

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Pessac, France

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Bad Soden, Germany

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Berlin, Germany

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Cologne, Germany

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Erlangen, Germany

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Hamburg, Germany

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Hamm, Germany

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Hanover, Germany

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Kiel, Germany

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Mainz, Germany

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Würselen, Germany

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Athens, Greece

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Pátrai, Greece

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Thessalonikis, Greece

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Luxembourg, Luxembourg

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Almada, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Barcelona, Spain

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Cadiz, Spain

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Málaga, Spain

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Salamanca, Spain

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Santiago de Compostela, Spain

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Seville, Spain

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Toledo, Spain

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Zaragoza, Spain

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Related Links

• A Phase II, Open-label Trial Using Velcade for Re-treatment of Multiple Myeloma Subjects Following an Initial Response to Velcade.

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 6, 2007
• Study Start: June 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

DE (10); FR (6); AU (3); GR (3); LU (1); ES (8); BE (4); PT (3)