Condition category
Cancer
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.C. Minnema

ORCID ID

Contact details

University Medical Centre Utrecht
Department of Haematology
B02.226
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2507230
m.c.minnema@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DLI-Velcade® study

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

interventional, non-randomised, non-controlled, multicentre trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Bortezomib (Velcade®), Donor Lymphocyte Infusion

Primary outcome measures

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 trial start date

01/05/2007

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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.

Recruitment start date

01/05/2007

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Utrecht (UMCU) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes