No registrations found.
ID
Source
Brief title
Health condition
Multiple Myeloma (Kahler¡¯s disease)
Sponsors and support
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.
Intervention
Outcome measures
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.
Background summary
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.
Study objective
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%.
Study design
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.
Intervention
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).
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
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
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2817 |
| NTR-old | NTR2958 |
| Other | HOVON : HO108 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |