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
Protocol serial number	N/A
Sponsor	University Medical Centre Utrecht (UMCU) (The Netherlands)
Funder	University Medical Centre Utrecht (UMCU) (The Netherlands)

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

Primary study design	Interventional
Study design	interventional, non-randomised, non-controlled, multicentre trial
Secondary study design	Non randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bortezomib (Velcade®), Donor Lymphocyte Infusion
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan