Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients
This study has been completed.
Sponsor:
Nordic Myeloma Study Group
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Nordic Myeloma Study Group
ClinicalTrials.gov Identifier:
NCT00417911
First received: January 3, 2007
Last updated: June 17, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Nordic Myeloma Study Group:
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 [ Time Frame: 1 year after randomization of the last patient ] [ Designated as safety issue: Yes ]
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
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: No treatment |
Drug: bortezomib
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
|
|
Experimental: Bortezomib consolidation
Bortezomib consolidation : 20 injections starting 3 months after ASCT
|
Drug: bortezomib
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417911
Locations
| Denmark | |
| Hæmatologisk afdeling L Amtssygehuset i Herlev | |
| Herlev, Denmark, DK-2730 | |
| Medicinsk Hæmatologisk afd L4042, Rigshospitalet | |
| København Ø, Denmark, DK-2100 | |
| Hæmatologisk afd X, Odense Universitetshospital | |
| Odense C, Denmark, DK-5000 | |
| Hæmatologisk afdeling B, Aalborg Sygehus Syd | |
| Ålborg, Denmark, DK-9000 | |
| Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset | |
| Århus C, Denmark, DK-8000 | |
| Finland | |
| Tampere University Hospital, Dep 10a | |
| Tampere, Finland, SF-33 521 | |
| Turku University Hospital, Dept. of Medicine, PL 52, | |
| Turku, Finland, SF-20521 | |
| Iceland | |
| Hemathology department, University State Hospital, Landspitali | |
| Reykjavik, Iceland, 101 | |
| Norway | |
| Hematologisk seksjon, med avd, Haukeland Universitetssykehus | |
| Bergen, Norway, N-5021 | |
| Hematologisk avdeling Ullevål Sykehus | |
| Oslo, Norway, N - 0407 | |
| Seksjon for blodsykdommer, Med. avd.,Rikshospitalet | |
| Oslo, Norway, N - 0027 | |
| Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge | |
| Tromsø, Norway, N-9038 | |
| Hematologisk seksjon Regionssykehuset | |
| Trondheim, Norway, N - 7006 | |
| Sweden | |
| Hematologiska klin, Huddinge sjukhus | |
| Huddinge, Sweden, SE-141 86 | |
| Hematologkliniken, Universitetssjukhuset | |
| Linköping, Sweden, SE-581 85 | |
| University Hospital Lund | |
| Lund, Sweden, SE-221 85 | |
| Medicinklin, Universitetssjukhuset MAS, | |
| Malmö, Sweden, SE-205 02 | |
| Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus | |
| Umeå, Sweden, SE-901 85 | |
| Medicinklin, Akademiska sjukhuset | |
| Uppsala, Sweden, SE-751 85 | |
| Medicinkliniken, Universitetssjukhuset | |
| Örebro, Sweden, SE-70185 | |
Sponsors and Collaborators
Nordic Myeloma Study Group
Janssen-Cilag Ltd.
Investigators
| Principal Investigator: | Ulf-Henrik Mellqvist, Dr., PhD | NMSG |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ulf-Henrik Melqvist, Nordic Myeloma Study Group, Sahlgrenska University Hospital Gothenborg |
| ClinicalTrials.gov Identifier: | NCT00417911 History of Changes |
| Other Study ID Numbers: | NMSG 15/05, EudraCT No: 2005-002756-18 |
| Study First Received: | January 3, 2007 |
| Last Updated: | June 17, 2010 |
| Health Authority: | Sweden: Medical Products Agency Sweden: Regional Ethical Review Board |
Keywords provided by Nordic Myeloma Study Group:
|
multiple myeloma autologous stem cell transplantation high-dose melphalan bortezomib |
consolidation event free survival phase III |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell 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 |
Melphalan Bortezomib Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013