Velcade Consolidation Bone Study

NCT01286077 | Completed Phase 2 Results

• 3 other identifiers: CR01627026866138MMY20602008-004264-39
• Study Type: interventional
• Target: 106
• Locations: 8 countries
• Sites: 21

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; bortezomib; hematology; bone marrow cancer; Myeloma-related bone disease; bone mineral density; bone markers

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)

  Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit

  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

• Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment

  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

  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

Secondary Outcomes (13)

• Progression Free Survival

  Baseline up to end of study (approximately 4 years 7 months)

• Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)

  Baseline up to end of study (approximately 4 years 7 months)

• Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)

  Baseline up to end of study (approximately 4 years 7 months)

• Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)

  Baseline up to end of study (approximately 4 years 7 months)

• Number of Patients With Skeletal Events

  Baseline up to end of study (approximately 4 years 7 months)

Study Arms (2)

bortezomib

EXPERIMENTAL

bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

Drug: bortezomib

Non-treated control

NO INTERVENTION

no treatment, observation only

Interventions

bortezomib DRUG

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.

bortezomib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (21)

Unknown Facility

Feldkirch, Austria

Location

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Graz, Austria

Location

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Vienna, Austria

Location

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Brno, Czechia

Location

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Vejle, Denmark

Location

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Hamburg, Germany

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Kiel, Germany

Location

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Mÿnchen, Germany

Location

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Athens, Greece

Location

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Huddinge, Sweden

Location

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Stockholm, Sweden

Location

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Adana, Turkey (Türkiye)

Location

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Ankara, Turkey (Türkiye)

Location

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Antalya, Turkey (Türkiye)

Location

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Eskişehir, Turkey (Türkiye)

Location

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Gebse, Turkey (Türkiye)

Location

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Istanbul, Turkey (Türkiye)

Location

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Izmir, Turkey (Türkiye)

Location

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Edinburgh, United Kingdom

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Sheffield Yorks, United Kingdom

Location

Unknown Facility

Wakefield, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma; Bone Marrow Neoplasms

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; Hematologic Neoplasms; Neoplasms by Site; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: EMEA Medical Affairs Director
• Organization: Janssen-Cilag Greece

+30 210 8090738

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: September 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2014
• Last Updated: May 30, 2016
• Results First Posted: December 30, 2013

Record last verified: 2016-04

Locations

AU (3); SE (2); TU (7); CZ (1); GR (1); GB (3); DK (1); DE (3)