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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26950

Enrollment

110

Registered

2011-06-29

Start date

2011-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma (Kahler¡¯s disease)

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-SC

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactH.M. Lokhorst

University Medical Center Utrecht (UMCU), Department of Hematology (B02.226), P.O. Box 85500

h.lokhorst@umcutrecht.nl+31 (0)88 7557230

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)