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Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma (REVALLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421927
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : July 23, 2015
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma
Study Start Date : August 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: lenalidomide Drug: Lenalidomide

Start between Day+100 and Day+120 post-transplant

- Initial dose: 5 mg/day every day

In the absence of thrombocytopenia < 75000/mm3 or neutropenia < 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day.

- Duration

  • until persistent stringent complete response for 3 months
  • or progression defined by IMWG criteria12
  • or unacceptable toxicity
  • or one year after transplant

Primary Outcome Measures :
  1. Safety of lenalidomide [ Time Frame: 1 year ]

    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

Secondary Outcome Measures :
  1. One-year Progression-Free Survival [ Time Frame: one year ]
    Progression defined according to International Myeloma Working Group (IMWG) criteria

  2. One-year Overall Survival [ Time Frame: one year ]
    all-cause death

  3. One-year Transplant Related Mortality [ Time Frame: one year ]
  4. One-year incidence of Relapse/Progression [ Time Frame: one year ]
    Progression defined according to IMWG criteria

  5. Incidences of acute and chronic Graft versus Host Disease [ Time Frame: one year ]
    Acute graft versus host disease according to Seattle criteria. Chronic graft versus host disease according to NIH criteria.

  6. Immunophenotypic analysis of blood B, T, NK and dendritic cells [ Time Frame: one year ]
  7. Chimerism analysis [ Time Frame: one year ]
  8. safety of lenalidomide [ Time Frame: one year ]
    all adverse events, graded according to NCI-CTCAE v3

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421927

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CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33600
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Stephane Vigouroux, Dr University Hospital, Bordeaux
Study Chair: Adélaïde DOUSSAU, Dr University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux Identifier: NCT01421927    
Other Study ID Numbers: CHUBX 2010/01
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Keywords provided by University Hospital, Bordeaux:
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents