|- candidate number||9955|
|- NTR Number||NTR2958|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-jun-2011|
|- Secondary IDs||HO108 HOVON|
|- Public Title||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.|
|- Scientific Title||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.|
|- ACRONYM||HOVON 108 MM|
|- hypothesis||For each of the two treatment arms separately:|
1. Null hypotheses (H0): Failure free duration (FFD) at 9 months post allo-SCT = 50%;
2. Alternative hypotheses (H1): FFD at 9 months post allo-SCT = 70%.
|- Healt Condition(s) or Problem(s) studied||Multiple myeloma (Kahler's disease)|
|- 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;
3. SD or better response after reinduction treatment;
4. 18-65 years,inclusive;
5. HLA-identical sibling or unrelated donor completely matched (10/10) (excluding identical twins);
6. WHO-performance status 0-2;
7. Written informed consent.
|- Exclusion criteria||1. Previous Allo-SCT;|
2. Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
3. Severe neurological or psychiatric disease;
4. Patients with neuropathy, CTC grade 2 or higher;
5. Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal);
6. Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
7. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
8. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or carcinoma in situ of the cervix or breast;
9. Patient known to be HIV-positive;
10. 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;
11. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or borium;
12. Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential;
13. Not able and not willing to use adequate contraception during therapy;
14. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
15. Severe cardiac dysfunction (NYHA classification II-IV).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2011|
|- planned closingdate||1-jul-2015|
|- Target number of participants||110|
|- Interventions||T cell depleted NMA Allo-SCT followed by 3 cycles of lenalidomide 10 mg/daily or lenalidomide 10 mg/daily combined with weekly bortezomib 1.3 mg/m2, and preemptive DLI. The conditioning of NMA Allo-SCT is performed with melphalan/fludarabine and in vitro and in
vivo T cell depletion with Alemtuzumab (for MUD in combination with ciclosporin).|
|- Primary outcome||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||1. To investigate the efficacy of this regimen in terms of complete remission rate, overall and progression free survival;|
2. To evaluate quality of life with these regimens.
|- Timepoints||1. At entry: Within three weeks before Allo-SCT;|
2. Within 2 weeks before first day of first consolidation cycle with lenalidomide and/or bortezomib;
3. During each cycle of lenalidomide and/or bortezomib;
4. Within two weeks before DLI and monthly after DLI;
5. During follow up every two months. All patients will be followed until 5 years after registration.
|- Trial web site||www.hovon.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dhr. Prof. Dr. H.M. Lokhorst|
|- CONTACT for SCIENTIFIC QUERIES||Dhr. Prof. Dr. H.M. Lokhorst|
|- Sponsor/Initiator ||Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), HOVON Data Center, Daniel den Hoed Cancer Center|
(Source(s) of Monetary or Material Support)
|Amgen, Dutch Cancer Society, Johnson & Johnson, Roche Nederland BV, Novartis|
|- Brief summary||Study phase: II.
Primary objective: 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.
1. To investigate the efficacy of this regimen in terms of complete remission rate, overall and progression free survival;
2. To evaluate quality of life with these regimens.
Prospective, multi center, randomized.
Duration of treatment:
9 months. Subsequently patients will be followed until 5 years after registration.
|- Main changes (audit trail)|
|- RECORD||29-jun-2011 - 6-jul-2011|