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.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2958
• Date of registration: 29/06/2011
• Primary sponsor: HOVON Data Center
• 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. - HOVON 108 MM
• Date of first enrolment: 1/7/2011
• Target sample size: 110
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2958
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: H.M. Lokhorst

• Name: H.M. Lokhorst

Key inclusion & exclusion 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: 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).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Multiple myeloma (Kahler's disease)

Intervention(s)

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(s)

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(s)

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.

Secondary ID(s)

HO108

Source(s) of Monetary Support

Amgen, Dutch Cancer Society, Johnson & Johnson, Roche Nederland BV, Novartis

Secondary Sponsor(s)

Daniel den Hoed Cancer Center

Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)