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

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ClinicalTrials.gov Identifier: NCT02537808
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

Brief 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.

Condition or disease
Multiple Myeloma

Detailed 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.

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Study Type : Observational
Actual Enrollment : 172 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
Actual Study Start Date : June 23, 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Progression-free survival (PFS) rate at 24 months [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To assess Median Overall Survival (OS) [ Time Frame: 84 month ]
  2. To assess safety and tolerability via AE and SAE reporting [ Time Frame: 24 months ]
    AE, SAE and ADR are documented in the eCRF and will be used for safety assessment.

  3. To assess Quality of Life (EORTC QLQ-C30 and MY20 [ Time Frame: 24 months ]
    QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months

  4. To assess duration of hospitalisation periods [ Time Frame: 24 months ]
    To estimate hospital resource utilization by documenting how much time (days/weeks) patients spend in the hospital during their treatment period.

  5. Overall Response Rate [ Time Frame: 24 months ]
  6. Median Progression-free survival (PFS) [ Time Frame: 84 months ]
  7. Median Time to Progression (TTP) [ Time Frame: 84 months ]
  8. Median Time to Response (TTR) [ Time Frame: 24 months ]
  9. Duration of Response [ Time Frame: 84 months ]
  10. Reason for treatment discontinuation [ Time Frame: 84 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Transplant-ineligible patients with previously untreated, symptomatic multiple myeloma (as defined by IMWG criteria) and with an indication for medical treatment as assessed by the investigator.
Criteria

Inclusion Criteria:

  • Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG)
  • Indication for treatment as assessed by the treating physician
  • Decision for first line combination therapy with lenalidomide and low-dose dexamethasone
  • 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 the SmPC Revlimid®) must be followed by female and male patients
  • Other criteria according to the SmPC. Special warnings and precautions of the SmPC have to be considered by the treating physician

Exclusion Criteria:

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

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 ClinicalTrials.gov identifier (NCT number): NCT02537808


Locations
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Germany
Hämatologisch-Onkologische Schwerpunktpraxis
Bochum, Germany, 44787
Sponsors and Collaborators
iOMEDICO AG
Investigators
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Principal Investigator: Holger Nückel, Professor Hämatologisch-Onkologische Schwerpunktpraxis
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT02537808    
Other Study ID Numbers: IOM-12315
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases