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Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma (PrObe-L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02692339
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : June 5, 2019
Information provided by (Responsible Party):

Brief Summary:
Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC).

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone

Detailed Description:

This study aims to assess the real-life safety of Lenalidomide/Dexamethasone (Len/Dex) in patients with (Relapsed or Refractory Multiple Myeloma (rrMM), by evaluation of adverse events of special interest (infections, gastrointestinal events, thrombocytopenia, neutropenia, febrile neutropenia, and thromboembolism). In addition, due to the scarce information regarding the impact of frailty in Len/Dex treatment in rrMM, this study will prospectively assess Len/Dex safety and effectiveness by patient frailty groups.

The following study assessments will be performed:

  • Recruitment: patients will be recruited within 15 days after the start of Len/Dex (from day 1 to day 15). In case patients are not recruited at the day of Len/Dex start (day 1), baseline information respective to this day will be collected retrospectively.
  • Treatment period: during this period, the following assessments will be carried out:

    • Every 30 days (± 5 days) for adverse events, changes in concomitant medication and change in Len/Dex dose.
    • Every 90 days (± 15 days) for the remaining information to be collected in the treatment period
  • Assessment at the end of Len/Dex treatment (until 5 days after end of treatment).

Follow-up assessment 90 days (± 15 days) after the end of Len/Dex treatment.

No visits were predefined for this study. Study data is planned to be collected when the patient goes to the study site for a clinical routine visit. No assessments will be imposed for the purposes of this study. If the patient goes to the clinical routine visit at a date out of the time intervals predicted above, no information will be collected. Information will be collected in the context of routine clinical practice.

The patient will be followed until the end of Len/Dex treatment, death or discontinuation for any reason for a maximum period of 36 months, Patients within treatment after this maximum period will stop being followed in the study.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : September 29, 2023

Group/Cohort Intervention/treatment
Standard of Care doses for relapsed/refractory multiple myeloma
Drug: Lenalidomide
Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle
Other Name: Revlimid

Drug: Dexamethasone
Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
Other Name: Decadron

Primary Outcome Measures :
  1. Number of Adverse events of special interest during Len/Dex therapy [ Time Frame: Up to approximately 72 months ]
    Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, i.e. any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Progression of the underlying disease of multiple myeloma is not considered an AE and should not be reported as an AE

Secondary Outcome Measures :
  1. Incidence (number) of thromboembolism [ Time Frame: Up to approximately 72 months ]
    Identification of the incidence of deep venous thrombosis and pulmonary embolism) during Lenalidomide and Dexamethasone study drug treatment.

  2. Duration of Len/Dex treatment over the course of the study [ Time Frame: Up to approximately 72 months ]
    Defined as the time between the start of Len/Dex treatment until discontinuation or death (whichever occurs first)

  3. Number of patients with good and poor compliance to lenalidomide and dexamethasone [ Time Frame: Up to approximately 72 months ]
    Compliance will be measured by the capsule/tablet count, after the end of study treatment

  4. Type and frequency of prophylaxis treatment for prevention of thromboembolism [ Time Frame: Up to 36 months ]
    Type and frequency of prophylaxis treatment for prevention of thromboembolism during Lenalidomide/Dexamethasone study treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:   Non-Probability Sample
Study Population
Relapsed and/or Refractory multiple myeloma patient population

Inclusion Criteria:

  1. Patients aged 18 years or higher.
  2. Patients who have voluntarily given written informed consent to participate in the study and have their data retrieved for the purposes of the study
  3. Patients diagnosed with 1st or 2nd relapsed or refractory multiple myeloma and indicated for 2nd or 3rd line Len/Dex treatment, according with the SmPC (patients who have received at least one prior therapy) -

Exclusion Criteria:

  1. Pregnant or lactating patients
  2. Female patients of childbearing potential unable or unwilling to use effective contraceptive methods, as stated in the summary of product characteristics:

    • Implant.
    • Levonorgestrel-releasing intrauterine system.
    • Medroxyprogesterone acetate depot.
    • Tubal sterilisation.
    • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses.

    Ovulation inhibitory progesterone-only pills (i.e. desogestrel).

    - Male patients unable to follow or comply with the required contraceptive measures stated in the SmPC (use of condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception [even if the man has had a vasectomy], during treatment and for 1 week after dose interruptions and/or cessation of treatment)

  3. Hypersensitivity to the active substance or any of the excipients
  4. Patients participating in a clinical trial -

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 identifier (NCT number): NCT02692339

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Contact: Sara Vieira

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Hospital Garcia Orta, E.P.E. Not yet recruiting
Almada, Portugal, 2805-267 Almada
Hospital Professor Doutor Fernando Fonseca, E.P.E. Not yet recruiting
Amadora, Portugal, 2720-276 Amadora
Hospital Central de Faro Not yet recruiting
Faro, Portugal, 8000-386 Faro
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE Not yet recruiting
Lisboa, Portugal, 1099-023 Lisboa
Centro Hospitalar Lisboa Central, EPE - Hospital de Sto. Ant. Capuchos Not yet recruiting
Lisboa, Portugal, 1169-050 Lisboa
Fundação Champalimaud Recruiting
Lisboa, Portugal, 1400-038 Lisboa
Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria Recruiting
Lisboa, Portugal, 1649-035 Lisboa
Centro Hospitalar do Porto - Hospital de Santo António Recruiting
Porto, Portugal, 4099-001 Porto
Instituto Português de Oncologia do Porto Francisco Gentil, EPE Not yet recruiting
Porto, Portugal, 4200-072 Porto
Centro Hospitalar de São João, EPE - Hospital de São João Recruiting
Porto, Portugal, 4200-319 Porto
Centro Hospitalar de Vila Nova de Gaia Not yet recruiting
Vila Nova de Gaia, Portugal, 4430-502 Vila Nova de Gaia
Hospital de São Teotónio, E.P.E. Not yet recruiting
Viseu, Portugal, 3504-509 Viseu
Sponsors and Collaborators
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Study Director: Isabel Boaventura, MD Celgene
Additional Information:

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Responsible Party: Celgene Identifier: NCT02692339    
Other Study ID Numbers: CC-5013-MM-028
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by Celgene:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Observational Study
Safety of Len/Dex
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents