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

University Medical Centre Utrecht
Department of Haematology, B02.226
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone +31 (0)30 2507230
Email m.c.minnema@umcutrecht.nl

Study information

Study designinterventional, non-randomised, non-controlled, multicentre trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymDLI-Velcade® study
Study objectivesThe 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) studiedMultiple myeloma
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bortezomib (Velcade®), Donor Lymphocyte Infusion
Primary outcome measureThe 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 measuresSecondary 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 date01/05/2007
Completion date01/05/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2007
Date of final enrolment01/05/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

Department of Haematology
P.O. Box 85500
Alkmaar
3508 GA
Netherlands

Website http://www.umcutrecht.nl/zorg/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan