Bortezomib re-induction therapy combined with donor lymphocyte infusion in patients with relapsed Multiple Myeloma following allogeneic stem cell transplantatio

Conditions: multiple myeloma patients with relapse or progression of their disease after receiving an allogeneic stem cell transplantation
MedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma

Registration Number: EUCTR2006-005007-34-NL

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

-Male or female and at least 18 years-of-age
-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)
-Informed consent
-Haematological parameters; Hb > 4.0 mmol/L, leucocytes > 1.0×109/L , thrombocytes > 25 ×109/L, with or without transfusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-use of immunosuppressive drugs, for example cyclosporin, MMF, corticosteroids
-existing GvHD > grade A
-any non-hematological toxicity CTC grade = 3
-neuropathy CTC grade = 2
-pregnancy
-previous use of bortezomib is not an exclusion criterion, however patients refractory to bortezomib during previous treatment are excluded from this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigation of the efficacy of bortezomib combined with Donor Lymphocyte Infusion in patients with relapsed or progressive multiple myeloma following (non) myeloablative allo-SCT as measured by<br>- response rate including percentage of complete remission according to EBMT criteria <br>- event free survival (EFS) (i.e. time from registration to progression or death from any cause whichever occurs first) and overall survival (OS).<br>;Secondary Objective: Investigation of the <br>- toxicity of DLI in combination with bortezomib including evaluation of GvHD and CTC grade toxicity<br>- evaluation of immune modulating effects of combined treatment consisting of DLI and bortezomib as measured by serial blood samples<br>;Primary end point(s): -CTC toxicity grade 4 <br> -GvHD grade D<br> -Response <br>

Secondary Outcome Measures