Bortezomib (Velcade®) therapy combined with Donor Lymphocyte Infusion in patients with relapsed multiple myeloma following allogeneic stem cell transplantation
| ISRCTN | ISRCTN53810679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53810679 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 21/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.C. Minnema
Scientific
Scientific
University Medical Centre Utrecht
Department of Haematology, B02.226
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2507230 |
|---|---|
| m.c.minnema@umcutrecht.nl |
Study information
| Study design | interventional, non-randomised, non-controlled, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DLI-Velcade® study |
| Study objectives | The combination of DLI with bortezomib given before and after the DLI improves the Graft versus Myeloma effect without effect on the Graft versus host disease |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple myeloma |
| Intervention | The intervention consists of a sequential approach over bortezomib cycli (2) with DLI. The bortezemib cycli are given before and 2 weeks after the DLI infusion. If the patient reaches a CR the treatment is stopped. If a PR is reached the patient continues with bortezomib, maximum 8 cycli. In case of a minimal reaction the patient can receive a second and third DLI, combined with bortezemib. During the study blood and bone marrow sampling will determine the response rate. This is no control group, comparison with historical data will be performed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bortezomib (Velcade®), Donor Lymphocyte Infusion |
| Primary outcome measure | The primary outcome is response rate. The included patients will be analysed with analysis of the m-protein at entry, after bortezomib cycle 2, 4, 6, 8 and before administration of DLI or before cycle 4,6,8 if no more DLI is given. After each DLI before administration of bortezomib cycle 3, 5, 7 and in follow up every 2 months. Bone marrow examination will be done on indication, for example confirmation of CR. |
| Secondary outcome measures | Secondary outcomes are evaluated at the same time points as the primary outcome. Blood samples for experimental immunology are taken before: 1. First administration of bortezomib in cycle one 2. First DLI 3. First administration of bortezomib in cycle three 4. Second DLI 5. First administration of bortezomib in cycle five 6. Third DLI 7. First administration of bortezomib in cycle seven 8. Stopped treatment and/or occurring GvHD |
| Overall study start date | 01/05/2007 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Male or female and at least 18 years-of-age; 2. MM patients with any type of relapse or progressive disease following (non) myeloablative allo-SCT for which DLI is considered a treatment option (including patients previously participating in Hovon 54 or Hovon 65 studies); 3. Informed consent; 4. Haematological parameters; Hb > 4.0 mmol/L, leucocytes > 1.0¡Á109/L , thrombocytes > 25 ¡Á109/L, with or without transfusion |
| Key exclusion criteria | 1. Use of the immunosuppressive drugs cyclosporin, MMF, or corticosteroids; 2. Existing GvHD > grade A; 3. Any non-hematological toxicity CTC grade ¡Ý 3; 4. Neuropathy and/or neuropathic pain CTC grade ¡Ý 2; 5. Pregnancy; 6. History of allergic reaction to compounds containing boron or mannitol; 7. Uncontrolled or severe cardiovascular disease, including myocardial infarctiin within 6 months, NYHA class III of IV heart failure (appendix E), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis; 8. Previous use of bortezomib is not an exclusion criterion, however patients refractory to bortezomib during previous treatments are excluded from this study. |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Haematology
P.O. Box 85500
Alkmaar
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Hospital/treatment centre
University Medical Centre Utrecht (UMCU) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
