Bortezomib and High-dose Melphalan at Myeloma Relapse
Recruitment status was Active, not recruiting
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Purpose
The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support |
- Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Response rate of the second ASCT [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Marrow regeneration [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- OS compared with the OS of matched controls from the former NMSG [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | September 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
-
Drug: bortezomib
Patients with multiple myeloma who have their first treatment demanding relapse after an initial treatment with high-dose melphalan with autologous stem cell support and who have more than 2.0 x 10^6 CD34+ stem cells pr kg bodyweight in the freezer can be included in the trial.
After disease status with basic clinical biochemistry, M-protein in blood and urine, bone marrow investigation including immunophenotyping and total skeletal x-ray the patients are treated with three courses of standard bortezomib (1.3 mg/sqm Days 1,4,8,11) and dexamethasone 20 mg days 1,2,4,5,8,9,11,12. Within 4 weeks the patients receive bortezomib days -5 and -2, high-dose melphalan (200 mg/sqm) day -2, and subsequent at least 2.0 x 10^6 CD34+ stem cells pr kg body weight.
The first month after high-dose therapy the patients are followed closely for toxicity according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), Version 3.0.
The patients are evaluated for response according to EBMT criteria and for event (death or progressive disease).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- First relapse after ASCT
- Symptomatic myeloma
- More than 2,0 x 10^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support
- Signed informed consent given prior to any study related activities have been performed
- Age > 18 years
Exclusion Criteria:
- Allogeneic transplantation scheduled as a part of the treatment
- Expected survival of less than one month.
- Performance status (WHO) > 3
- Neuropathy > Grade 3 (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 melphalan, dexamethasone, 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| Denmark | |
| Department of Haematology B, Aalborg Hospital, University of Aarhus | |
| Aalborg, Denmark, 9000 | |
| Department of Haematology, Herlev University Hospital | |
| Herlev, Denmark, 2730 | |
| Department of Haematology X, Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Dept. of Haematology, Århus University Hospital | |
| Århus, Denmark, 8000 | |
| Norway | |
| Hematologisk seksjon, med avd, Haukeland Universitetssykehus | |
| Bergen, Norway, N-5021 | |
| Department of Hematology, Rikshospitalet | |
| Oslo, Norway | |
| Hematologisk seksjon, St.Olav Hospital | |
| Trondheim, Norway, N-7006 | |
| Sweden | |
| Department of Hematology, Sahlgrenska Sjukhuset | |
| Göteborg, Sweden | |
| University Hospital Lund | |
| Lund, Sweden, SE-221 85 | |
| Principal Investigator: | Peter Gimsing, M.D. | Department of Haematology, Rigshospitalet |
More Information
No publications provided
| Responsible Party: | Peter Gimsing, Nordic Myeloma Study Group, Rigshospitalet |
| ClinicalTrials.gov Identifier: | NCT00508209 History of Changes |
| Other Study ID Numbers: | NMSG 16-07, EudraCT nr 2006-007022-64, KF 02 2006-7206, LMS 2612-3390 |
| Study First Received: | July 26, 2007 |
| Last Updated: | June 17, 2010 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Nordic Myeloma Study Group:
|
high-dose melphalan bortezomib response toxicity relapse |
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 June 18, 2013