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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005007-34-NL

Enrollment

Registered

2006-10-04

Start date

2007-04-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - response rate including percentage of complete remission according to EBMT criteria - event free survival (EFS) (i.e. time from registration to progression or death from any cause whichever occurs first) and overall survival (OS). ;Secondary Objective: Investigation of the - toxicity of DLI in combination with bortezomib including evaluation of GvHD and CTC grade toxicity - evaluation of immune modulating effects of combined treatment consisting of DLI and bortezomib as measured by serial blood samples ;Primary end point(s): -CTC toxicity grade 4 -GvHD grade D -Response	—

Measure

Time frame

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 - response rate including percentage of complete remission according to EBMT criteria - event free survival (EFS) (i.e. time from registration to progression or death from any cause whichever occurs first) and overall survival (OS). ;Secondary Objective: Investigation of the - toxicity of DLI in combination with bortezomib including evaluation of GvHD and CTC grade toxicity - evaluation of immune modulating effects of combined treatment consisting of DLI and bortezomib as measured by serial blood samples ;Primary end point(s): -CTC toxicity grade 4 -GvHD grade D -Response

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026