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Clinical Trials/NL-OMON36688
NL-OMON36688
Completed
Phase 2

A randomized phase II study for the 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 - HO108 MM

HOVO0 sites110 target enrollmentTBD
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ConditionsKahlers diseaseMultiple Myeloma10035227

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Kahlers disease
Sponsor
HOVO
Enrollment
110
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
HOVO

Eligibility Criteria

Inclusion Criteria

  • •\- Patients with multiple myeloma with a first relapse or progression after first line therapy;
  • •\- Relapsed or progressive patients have received reinduction therapy before entering this trial;
  • •\- At least PR after reinduction treatment;
  • •\- 18\-65 years,inclusive
  • •\- HLA\-identical sibling or unrelated donor completely matched (10/10\) (excluding identical
  • •\- WHO\-performance status 0\-2;
  • •\- Written informed consent

Exclusion Criteria

  • •\- No previous Allo\-SCT;
  • •\- Severe pulmonary dysfunction (CTCAE grade III\-IV, see protocol appendix D );
  • •\- Severe neurological or psychiatric disease;
  • •\- Patients with neuropathy, CTC grade 3 or higher;
  • •\- Significant hepatic dysfunction (serum bilirubin or transaminases \* 3 times upper limit of
  • •\- Significant renal dysfunction (creatinine clearance \< 30 ml/min after rehydration);
  • •\- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes,
  • •infection, hypertension, cancer, etc.);
  • •\- History of active malignancy during the past 5 years with the exception of basal carcinoma of
  • •the skin or or carcinoma \*in situ\* of the cervix or breast;

Outcomes

Primary Outcomes

Not specified

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