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%.
ID
Bron
Verkorte titel
Aandoening
Multiple Myeloma (Kahler¡¯s disease)
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
In addition HOVON is supported by the Dutch Cancer Society.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Study phase: II.
Study objective:
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.
Secondary objectives:
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.
Study design:
Prospective, multi center, randomized.
Duration of treatment:
9 months. Subsequently patients will be followed until 5 years after registration.
Doel van het onderzoek
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%.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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).
Publiek
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Wetenschappelijk
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2817 |
| NTR-old | NTR2958 |
| Ander register | HOVON : HO108 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |