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

Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma

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).

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Portugal
  • Almada, Portugal, 2805-267 Almada
    • Hospital Garcia Orta, E.P.E.
  • Amadora, Portugal, 2720-276 Amadora
    • Hospital Professor Doutor Fernando Fonseca, E.P.E.
  • Faro, Portugal, 8000-386 Faro
    • Hospital Central de Faro
  • Lisboa, Portugal, 1099-023 Lisboa
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
  • Lisboa, Portugal, 1169-050 Lisboa
    • Centro Hospitalar Lisboa Central, EPE - Hospital de Sto. Ant. Capuchos
  • Lisboa, Portugal, 1400-038 Lisboa
    • Fundacao Champalimaud
  • Lisboa, Portugal, 1649-035 Lisboa
    • Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria
  • Porto, Portugal, 4099-001 Porto
    • Centro Hospitalar do Porto - Hospital de Santo António
  • Porto, Portugal, 4200-072 Porto
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
  • Porto, Portugal, 4200-319 Porto
    • Centro Hospitalar de São João, EPE - Hospital de São João
  • Vila Nova de Gaia, Portugal, 4430-502 Vila Nova de Gaia
    • Centro Hospitalar de Vila Nova de Gaia
  • Viseu, Portugal, 3504-509 Viseu
    • Hospital de São Teotónio, E.P.E.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Relapsed and/or Refractory multiple myeloma patient population

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lenalidomide/Dexamethasone; 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 Names: 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 Names: Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse events of special interest during Len/Dex therapy	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	Up to approximately 72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence (number) of thromboembolism	Identification of the incidence of deep venous thrombosis and pulmonary embolism) during Lenalidomide and Dexamethasone study drug treatment.	Up to approximately 72 months
Duration of Len/Dex treatment over the course of the study	Defined as the time between the start of Len/Dex treatment until discontinuation or death (whichever occurs first)	Up to approximately 72 months
Number of patients with good and poor compliance to lenalidomide and dexamethasone	Compliance will be measured by the capsule/tablet count, after the end of study treatment	Up to approximately 72 months
Type and frequency of prophylaxis treatment for prevention of thromboembolism	Type and frequency of prophylaxis treatment for prevention of thromboembolism during Lenalidomide/Dexamethasone study treatment.	Up to 36 months

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Isabel Boaventura, MD, Celgene

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2016
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 12, 2018

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Lenalidomide; Observational Study; Dexamethasone; Refractory Multiple Myeloma; Relapsed Multiple Myeloma; Safety of Len/Dex
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Lenalidomide
• Other Study ID Numbers: CC-5013-MM-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No