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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)


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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)


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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate to RAD induction and transplant (stringent CR, CR, very good PR)

Outcome Time Frame:

9 months from start of treatment

Safety Issue:

No

Principal Investigator

Ralf C Bargou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wuerzburg University Hospital, Dept. of Internal Medicine II

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

DSMM XII

NCT ID:

NCT00925821

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Allogeneic stem cell transplantation
  • Lenalidomide
  • IMiD
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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