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NCT Number: NCT00925821

Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

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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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité University Hospital - Virchow Klinikum, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogeneic stem cell transplant versus second autologous transplantation

Procedure

Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²

RAD

Drug

After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.

Primary outcomes

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

    Time frame: 9 months from start of treatment

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 9 months from start of treatment

  2. Incidence and relationship of severe adverse events

    Time frame: 1 year from start of treatment

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Amgen
  • Celgene Corporation
  • ClinAssess GmbH
  • medac GmbH

Registry information

Official study 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)

Important dates

Study start
2009
First posted
Jun 22, 2009
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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