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Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Nordic Myeloma Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, autologous stem cell transplantation, high-dose melphalan, bortezomib, consolidation, event free survival, phase III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic myeloma diagnosis according to criteria in attachment 3
  • ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy
  • Signed informed consent given prior to any study related activities have been performed

Exclusion Criteria:

  • Prior exposure to bortezomib
  • Allogeneic transplantation scheduled as a part of the primary treatment
  • Neuropathy > Grade 2 (neurological symptoms interfering with ADL)
  • Non-secreting myeloma
  • Other concurrent disease making bortezomib treatment unsuitable
  • Positive pregnancy test (only applicable for women with childbearing potential)
  • Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
  • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
  • History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg)
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study

Sites / Locations

  • Hæmatologisk afdeling L Amtssygehuset i Herlev
  • Medicinsk Hæmatologisk afd L4042, Rigshospitalet
  • Hæmatologisk afd X, Odense Universitetshospital
  • Hæmatologisk afdeling B, Aalborg Sygehus Syd
  • Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset
  • Tampere University Hospital, Dep 10a
  • Turku University Hospital, Dept. of Medicine, PL 52,
  • Hemathology department, University State Hospital, Landspitali
  • Hematologisk seksjon, med avd, Haukeland Universitetssykehus
  • Seksjon for blodsykdommer, Med. avd.,Rikshospitalet
  • Hematologisk avdeling Ullevål Sykehus
  • Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge
  • Hematologisk seksjon Regionssykehuset
  • Hematologiska klin, Huddinge sjukhus
  • Hematologkliniken, Universitetssjukhuset
  • University Hospital Lund
  • Medicinklin, Universitetssjukhuset MAS,
  • Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus
  • Medicinklin, Akademiska sjukhuset
  • Medicinkliniken, Universitetssjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No treatment

Bortezomib consolidation

Arm Description

Bortezomib consolidation : 20 injections starting 3 months after ASCT

Outcomes

Primary Outcome Measures

Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation

Secondary Outcome Measures

Overall survival from ASCT
Overall survival from start of relapse treatment
Time to need for relapse treatment
Response rate in patients not in CR following ASCT
Toxicity from consolidation treatment
Quality of life
Cost utility
Planned subgroup analysis: comparison of primary and secondary endpoint in patients receiving one vs. two high dose treatments

Full Information

First Posted
January 3, 2007
Last Updated
June 17, 2010
Sponsor
Nordic Myeloma Study Group
Collaborators
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00417911
Brief Title
Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients
Official Title
Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nordic Myeloma Study Group
Collaborators
Janssen-Cilag Ltd.

4. Oversight

5. Study Description

Brief Summary
Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in younger patients. However, the disease will eventually relapse and new treatment is demanded. Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a different biological effect and response even in patients refractory to conventional chemotherapy. The purpose of the study is in a randomized design to investigate if addition of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can prolong the time to progression compared to patients receiving no consolidation or maintenance therapy.
Detailed Description
Rationale: ASCT prolongs EFS and OS for myeloma patients < 65 years of age. During the period from ASCT to progression most myeloma patients experience few symptoms and have a good quality of life11. A further prolongation of EFS would be a big step forward in myeloma treatment. Bortezomib is a new promising agent, which has shown clear anti-myeloma effect in heavily pre-treated patients. After ASCT the tumour cell burden is low and it is the hypothesis of this clinical trial that the unique mechanism of action of bortezomib may reduce the number of tumour cells even further and by doing so prolong EFS. Primary objective: * Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation Secondary objectives: Overall survival from ASCT Overall survival from start of relapse treatment Time to need for relapse treatment Response rate in patients not in CR following ASCT Toxicity from consolidation treatment Quality of life Cost utility Planned subgroup analysis: comparison of primary and secondary endpoint in patients receiving one vs. two high dose treatments

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, autologous stem cell transplantation, high-dose melphalan, bortezomib, consolidation, event free survival, phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No treatment
Arm Type
Active Comparator
Arm Title
Bortezomib consolidation
Arm Type
Experimental
Arm Description
Bortezomib consolidation : 20 injections starting 3 months after ASCT
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Description
Bortezomib 1,3 mg/sqm Days 1,4,8,11 for two 3-week cycles and then once a week for three weeks in 4 4-week cycles
Primary Outcome Measure Information:
Title
Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation
Time Frame
1 year after randomization of the last patient
Secondary Outcome Measure Information:
Title
Overall survival from ASCT
Title
Overall survival from start of relapse treatment
Title
Time to need for relapse treatment
Title
Response rate in patients not in CR following ASCT
Title
Toxicity from consolidation treatment
Title
Quality of life
Title
Cost utility
Title
Planned subgroup analysis: comparison of primary and secondary endpoint in patients receiving one vs. two high dose treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic myeloma diagnosis according to criteria in attachment 3 ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy Signed informed consent given prior to any study related activities have been performed Exclusion Criteria: Prior exposure to bortezomib Allogeneic transplantation scheduled as a part of the primary treatment Neuropathy > Grade 2 (neurological symptoms interfering with ADL) Non-secreting myeloma Other concurrent disease making bortezomib treatment unsuitable Positive pregnancy test (only applicable for women with childbearing potential) Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg) Serious medical or psychiatric illness likely to interfere with participation in this clinical study Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf-Henrik Mellqvist, Dr., PhD
Organizational Affiliation
NMSG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hæmatologisk afdeling L Amtssygehuset i Herlev
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Medicinsk Hæmatologisk afd L4042, Rigshospitalet
City
København Ø
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Hæmatologisk afd X, Odense Universitetshospital
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Hæmatologisk afdeling B, Aalborg Sygehus Syd
City
Ålborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset
City
Århus C
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Tampere University Hospital, Dep 10a
City
Tampere
ZIP/Postal Code
SF-33 521
Country
Finland
Facility Name
Turku University Hospital, Dept. of Medicine, PL 52,
City
Turku
ZIP/Postal Code
SF-20521
Country
Finland
Facility Name
Hemathology department, University State Hospital, Landspitali
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Facility Name
Hematologisk seksjon, med avd, Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Seksjon for blodsykdommer, Med. avd.,Rikshospitalet
City
Oslo
ZIP/Postal Code
N - 0027
Country
Norway
Facility Name
Hematologisk avdeling Ullevål Sykehus
City
Oslo
ZIP/Postal Code
N - 0407
Country
Norway
Facility Name
Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge
City
Tromsø
ZIP/Postal Code
N-9038
Country
Norway
Facility Name
Hematologisk seksjon Regionssykehuset
City
Trondheim
ZIP/Postal Code
N - 7006
Country
Norway
Facility Name
Hematologiska klin, Huddinge sjukhus
City
Huddinge
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Hematologkliniken, Universitetssjukhuset
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
University Hospital Lund
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Medicinklin, Universitetssjukhuset MAS,
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden
Facility Name
Medicinklin, Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Medicinkliniken, Universitetssjukhuset
City
Örebro
ZIP/Postal Code
SE-70185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23616624
Citation
Mellqvist UH, Gimsing P, Hjertner O, Lenhoff S, Laane E, Remes K, Steingrimsdottir H, Abildgaard N, Ahlberg L, Blimark C, Dahl IM, Forsberg K, Gedde-Dahl T, Gregersen H, Gruber A, Guldbrandsen N, Haukas E, Carlson K, Kvam AK, Nahi H, Lindas R, Andersen NF, Turesson I, Waage A, Westin J; Nordic Myeloma Study Group. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial. Blood. 2013 Jun 6;121(23):4647-54. doi: 10.1182/blood-2012-11-464503. Epub 2013 Apr 24.
Results Reference
derived

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Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients

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