Velcade Consolidation Bone Study
This study is ongoing, but not recruiting participants.
Sponsor:
Janssen-Cilag International NV
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01286077
First received: January 27, 2011
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to assess the effect of bortezomib on myeloma-related bone disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who have received high dose chemotherapy and autologous stem cell transplantation for primary treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study treatment assigned by chance like flipping a coin) to either bortezomib or observation alone. Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles. All subjects will be followed for a total of 24 months after randomization.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Effect of VELCADE on Myeloma Related Bone Disease |
Resource links provided by NLM:
Further study details as provided by Janssen-Cilag International NV:
Primary Outcome Measures:
- Change from baseline in bone mineral density (BMD) at end of Treatment [ Time Frame: at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier ] [ Designated as safety issue: No ]Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit
Secondary Outcome Measures:
- Progression Free Survival [ Time Frame: At each visit (10 to 22 visits in total) from screening to 18 months after end of treatment (approximately 24 months after randomization) ] [ Designated as safety issue: No ]Progression-free survival (PFS) defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY, to Progressive Disease, relapse from Complete Response, or death
- Change from Baseline in Biochemical Bone Markers [ Time Frame: baseline, Day 1 of cycle 3, EOT visit (24 weeks after randomization or until start of alternative MMY therapy, if earlier) and 10, 12,18 and 24 months after randomization ] [ Designated as safety issue: No ]Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), carboxyterminal collagen crosslinks (CTX-I), osteocalcin (Oc), bone-specific alkaline phosphatase (BAP) and Dickkopf homolog 1 (DKK-1)) will be measured on serum samples.
- Skeletal Events [ Time Frame: At each visit from screening to 18 months after end of treatment (approximately 24 months after randomization ] [ Designated as safety issue: No ]Number of subjects with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period
- Appearance of New Bone Lesions Compared to Baseline [ Time Frame: at screening, EOT (24 weeks after randomization or until start of alternative MMY therapy, if earlier) and 24 months after baseline ] [ Designated as safety issue: No ]Appearance of new bone lesions assessed by skeletal survey compared to baseline
- Change from Baseline in BMD over Time [ Time Frame: at Day 1 of Cycle 3 or Day 71 in the observation arm, and 12, 18, and 24 months after baseline ] [ Designated as safety issue: No ]Change from baseline in BMD will be assessed by dual energy x-ray absorptiometry scans
- Change in Karnofsky Performance Status [ Time Frame: at screening, Day 1 of Cycle 2, 3, and 4 or Day 36, 71 and 106 for observation arm, at EOT Visit, and every Follow-up Visit until 24 months after randomisation or start of alternative MMY therapy, if earlier ] [ Designated as safety issue: No ]Change in Karnofsky Performance Status compared to screening. The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is "perfect" health and 0 is death.
- Overall Survival [ Time Frame: At each visit (10 to 22 visits in total) from screening to 18 months after end of treatment (approximately 24 months after randomization) ] [ Designated as safety issue: No ]Overall survival defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY to date of death
| Enrollment: | 106 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | April 2014 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Drug: bortezomib
Each cycle will consist of 5 weeks treatment. Subjects in the treatment group will receive: Velcade® 1.6 mg/m2 as an intravenous bolus injection on Days 1, 8, 15, and 22 of each cycle followed by a 13-day rest period (Days 23 to 35) Cycle will be repeated on Day 36. Subjects in the treatment group will receive up to 4 treatment cycles, unless they experience either unacceptable toxicity or if the subject requests to withdraw from the study.
|
|
No Intervention: Non-treated control
no treatment, observation only
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult Multiple Myeloma patients in partial response or better after high dose chemotherapy and autologous stem cell transplantation
- Patient fulfills defined laboratory requirements within 14 days before enrolment
- If female, is either postmenopausal for more than 24 consecutive months or surgically sterilized or willing to use an acceptable method of birth control for defined period
- If male, agree to use an acceptable barrier method of contraception and to not donate sperm up to 3 months following treatment
Exclusion Criteria:
- Patient received another antimyeloma or experimental therapy following autologous stem cell transplantation
- Patient has a peripheral neuropathy or neuropathic pain of grade 2 or greater intensity as defined by the NCI common terminology criteria of adverse event (NCI CTCAE) version 3.0
- Patient has an uncontrolled or severe cardiovascular disease within 6 months of enrolment
- Patient has any conditions that would compromise his/her well-being or the completion of the study requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286077
Locations
| Austria | |
| Feldkirch N/A, Austria | |
| Graz, Austria | |
| Wien, Austria | |
| Czech Republic | |
| Brno, Czech Republic | |
| Denmark | |
| Vejle, Denmark | |
| Germany | |
| Hamburg, Germany | |
| Kiel, Germany | |
| Mÿnchen, Germany | |
| Greece | |
| Athens, Greece | |
| Sweden | |
| Huddinge, Sweden | |
| Stockholm, Sweden | |
| Turkey | |
| Adana, Turkey | |
| Ankara, Turkey | |
| Antalya, Turkey | |
| Eskisehir, Turkey | |
| Gebse, Turkey | |
| Istanbul, Turkey | |
| Izmir, Turkey | |
| United Kingdom | |
| Edinburgh, United Kingdom | |
| Sheffield Yorks, United Kingdom | |
| Wakefield, United Kingdom | |
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
| Study Director: | Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV |
More Information
No publications provided
| Responsible Party: | Janssen-Cilag International NV |
| ClinicalTrials.gov Identifier: | NCT01286077 History of Changes |
| Other Study ID Numbers: | CR016270, 26866138MMY2060, 2008-004264-39 |
| Study First Received: | January 27, 2011 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Keywords provided by Janssen-Cilag International NV:
|
Multiple Myeloma bortezomib hematology bone marrow cancer |
Myeloma-related bone disease bone mineral density bone markers |
Additional relevant MeSH terms:
|
Bone Diseases Multiple Myeloma Neoplasms, Plasma Cell Musculoskeletal Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013