A study of the effect of donor stem cell transplantation followed by treatment with lenalidomide or lenalidomide with bortezomib and subsequent DLI for patients with a relapse or progression following first line therapy

• Conditions: Patients, 18-65 years, inclusive, multiple myeloma with a first relapse or progression after first line therapy (with a HLA- identical sibling or unrelated donor completely matched (10/10)); MedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-018494-37-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-30
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients with multiple myeloma with a first relapse or with progression after first line therapy;
•Relapsed or progressive patients have received reinduction therapy before entering this trial;
•At least PR after reinduction treatment;
•18-65 years,inclusive;
•HLA-identical sibling or unrelated donor completely matched (10/10) (excluding identical twins);
•WHO-performance status 0-2;
•Written informed consent.

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•No previous Allo-SCT;
•Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
•Severe neurological or psychiatric disease;
•Patients with neuropathy, CTC grade 3 or higher;
•Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times upper limit of normal);
•Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
•Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
•History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or or carcinoma in situ” of the cervix or breast;
•Patient known to be HIV-positive;
•Patients with brain disease with the exception of those patients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months;
•The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or borium;
•Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential;
•Not able and not willing to use adequate contraception during therapy;
•Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
•Severe cardiac dysfunction (NYHA classification II-IV, see appendix E).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified