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Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma

Phase 1
18 Years
65 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma

Lenalidomide has a significant clinical activity in patients with relapsed or refractory MM
and in patients relapsing after Allo-SCT. The mechanisms of action involve immunomodulation,
anti-angiogenesis activity, direct anti tumor activity and effects on microenvironment. So
far, the experience with lenalidomide after Allo-SCT has been limited to patients with
progressive disease. In such patients, some responses are observed but most of them are
transient with median progression-free survivals of less than one year. Lenalidomide used as
maintenance therapy in patients with persistent rather than progressive disease might be a
better approach.

Lenalidomide is interesting in the Allo-SCT setting also because some recent studies
focusing on its immunological properties have suggested that the molecule could stimulate
the graft versus myeloma effect. First, it has been demonstrated in vitro that lenalidomide
can inhibit the proliferation and the suppressor function of regulatory T cells. Secondly, a
clinical study using lenalidomide as salvage therapy after Allo-SCT demonstrated an increase
of activated T cells and NK cells. Finally, a case report described a patient's response to
lenalidomide associated with the development of an acute graft versus host disease.

Taken together, these data suggest that patients with MM who have a persistent disease after
a reduced-intensity Allo-SCT might benefit from a post-transplant maintenance strategy with
lenalidomide by a direct anti-tumor effect and a stimulation of the graft versus myeloma
effect. The primary objective of this study is to evaluate the safety of such a strategy.

Inclusion Criteria:

- Patients aged 18 to 65 years

- Multiple Myeloma in 2nd or 3rd complete or partial response*

- Disease never refractory to lenalidomide

- Lenalidomide treatment ≤ 9 months

- HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high
resolution level or HLA-DQ high or low resolution level)

- Insured under Social Security

- Information and consent signed

Exclusion Criteria:

- Stable or progressive disease

- Hypersensitivity to lenalidomide or excipients

- Lenalidomide treatment > 9 months

- Absence of efficient contraception in women or men

- Cardiac insufficiency (ejection fraction < 50% by echocardiography)

- Pulmonary disease characterized by DLCO < 60%

- Severe renal insufficiency (clearance of creatinin < 30 ml/min)

- Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin > 2 times
the upper normal value except in case of Gilbert's disease

- Bacterial, Viral or Fungal uncontrolled infections

- No contraceptive method for Female subjects of childbearing potential

- No use of condoms for males subjects

- Pregnant or breast feeding woman

- History of previous cancer (other than myeloma) except if the patient is in complete
remission for more than 5 years.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of lenalidomide

Outcome Description:

The main judgement criteria will be the occurrence of adverse events (AE) requiring the definitive interruption of lenalidomide : Grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 occurring at the lowest dose of lenalidomide or Steroid-refractory acute (Seattle criteria) or chronic (National Institutes of Health (NIH) criteria) graft versus host disease or Transplant-related death

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Stephane Vigouroux, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2010/01



Start Date:

August 2011

Completion Date:

August 2014

Related Keywords:

  • Multiple Myeloma
  • lenalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell