A randomized phase II study for evaluation of T cell depleted non myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapy.
Recruiting
- Conditions
- Multiple Myeloma (Kahler¡¯s disease)
- Registration Number
- NL-OMON26950
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
1. Patients with multiple myeloma with a first relapse or progression after first line therapy;
2. Relapsed or progressive patients have received reinduction therapy before entering this trial;
Exclusion Criteria
1. Previous Allo-SCT;
2. Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib, and subsequent DLI; as treatment of relapsed multiple myeloma.
- Secondary Outcome Measures
Name Time Method 1. To investigate the efficacy of this regimen in terms of complete remission rate, overall and progression free survival;<br /><br>2. To evaluate quality of life with these regimens.