Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma

Last updated: November 16, 2023
Sponsor: iOMEDICO AG
Overall Status: Completed

Phase

N/A

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT02537808
IOM-12315
  • Ages > 18
  • All Genders

Study Summary

The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (asdefined by IMWG)
  • Indication for treatment as assessed by the treating physician
  • Decision for first line combination therapy with lenalidomide and low-dosedexamethasone
  • No previous systemic therapy for multiple myeloma
  • Ineligibility for transplantation
  • Aged 18 years or older
  • Written informed consent signed
  • The conditions of the risk management plan/pregnancy prevention program (refer to theSmPC Revlimid®) must be followed by female and male patients
  • Other criteria according to the SmPC. Special warnings and precautions of the SmPChave to be considered by the treating physician

Exclusion

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Any objections or contraindications according to the SmPC

Study Design

Total Participants: 172
Study Start date:
June 23, 2015
Estimated Completion Date:
September 13, 2023

Study Description

The introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. A variety of treatment options is now available for elderly patients. To compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (Rd) until progression vs. Rd for 18 cycles/72 weeks (Rd18) vs. melphalan, prednisone and thalidomide (MPT) for 12 cycles/72 weeks a multicenter, open-label phase III study (MM-020/IFM 07-01, FIRST trial) was performed in transplant ineligible patients.

After market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the FIRST-NIS is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.

Connect with a study center

  • Hämatologisch-Onkologische Schwerpunktpraxis

    Bochum, 44787
    Germany

    Site Not Available

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