Bortezomib therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantation

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR949
• Date of registration: 11/04/2007
• Primary sponsor: University Medical Center Utrecht (UMCU), Department of Hematology
• Public title: Bortezomib therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantation
• Scientific title: Bortezomib therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantation - DLI-Velcade studie
• Date of first enrolment: 1/5/2007
• Target sample size: 20
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=949
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: M.C. Minnema

• Name: M.C. Minnema

Key inclusion & exclusion criteria

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

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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Multiple myeloma (Kahler's disease), Allogeneic stem cell transplantation, Donor , Bortezomib, Lymphocytes, Infusion

Intervention(s)

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.

Primary Outcome(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.

Secondary Outcome(s)

Secondary outcomes are evaluated at the same time points as the primary outcome. Blood samples for experimental mmunology are taken before first gift bortezomib in cycle 1, before first DLI, before first gift bortezomib cycle 3, before DLI nr 2, before first gift bortezomib
cycle 5, before DLI nr 3, before first gift bortezomib cycle 7 and by stopping treatment and/or by occurring GvHD.

Secondary ID(s)

ISRCTN53810679

Source(s) of Monetary Support

University Medical Center Utrecht (UMCU), Department of Hematology