Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003749

Trial Description

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Title

Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment
are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is
permitted. After enrollment, patients are to receive four cycles of RAD induction treatment:
a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a
minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide,
etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan
chemotherapy followed by a first stem cell transplant. If any of the high-risk features
(such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A
isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic
transplant following dose-reduced conditioning. If no appropriate donor is available, the
patient does not consent or lacks of high-risk features a second autograft following
high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance
(one year) following hematopoietic reconstitution.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003749
  •   2012/05/03
  •   2009/06/16
  •   yes
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Secondary IDs

  •   NCT00925821  (ClinicalTrials.gov)
  •   DSMM XII  (University of Wuerzburg)
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Health Condition or Problem studied

  •   Multiple Myeloma
  •   C90.0 -  Multiple myeloma
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Interventions/Observational Groups

  •   Procedure: allogeneic stem cell transplant versus second autologous transplantation
  •   Drug: RAD
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Response rate to RAD induction and transplant (stringent CR, CR, very good PR); time frame: 9 months from start of treatment

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Secondary Outcome

- Progression-free survival (PFS); time frame: 9 months from start of treatment
- Incidence and relationship of severe adverse events; time frame: 1 year from start of treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2009/06/30
  •   146
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- Written informed consent

- Newly diagnosed multiple myeloma

- Maximum of one prior systemic therapy (2 cycles)

- Presence of CRAB criteria

- Measurable disease parameters

- Left ventricular ejection fraction at least 55%

- DLCO of at least 60%

- Adequate bone marrow function

- Use of adequate contraception for female subjects with childbearing potential and all
male subjects

- Eligible for autologous and allogeneic stem cell transplantation

- Bone marrow baseline sample evaluable for interphase cytogenetics

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Exclusion Criteria

- Any serious medical conditions preventing the subject from written informed consent

- Progressive disease (PD) to any initial treatment

- Pregnant or lactating females

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data

- Use of any other experimental drug or therapy within 28 days of baseline

- Preexisting neuropathy of ≥ grade 2 severity

- Known hypersensitivity to thalidomide

- Any prior use of lenalidomide

- Positive for HIV or infectious hepatitis, type A, B or C after serologic testing

- Serum creatinine despite induction therapy ≥ 2.0 mg/dL

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Addresses

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    • Wuerzburg University Hospital
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    • Wuerzburg University Hospital, Dept. of Internal Medicine II
    • Ralf C Bargou, MD 
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    • Wuerzburg University Hospital, Dept. of Internal Medicine II
    • Ralf C Bargou, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   94
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.