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Trial record 37 of 371 for:    LENALIDOMIDE AND Dexamethasone

Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot Study

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ClinicalTrials.gov Identifier: NCT03903406
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Multinational Center for Quality of Life Research, Russia

Brief Summary:
The purpose of this pilot study is to examine changes in patient-reported outcomes in patients with RRMM receiving triple therapy with ixazomib in combination with LenDex in a real world setting as well as to analyze clinical outcomes and safety of this treatment modality.

Condition or disease Intervention/treatment
Relapsed and/or Refractory Multiple Myeloma Drug: ixazomib in combination with lenalidomide and dexamethasone

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021



Intervention Details:
  • Drug: ixazomib in combination with lenalidomide and dexamethasone
    Patients with RRMM who have received at least one prior therapy will receive Ixazomib in combination with lenalidomide and dexamethasone within the routine clinical practice in accordance with prescription. Duration of therapy - until disease progression or unacceptable toxicity.


Primary Outcome Measures :
  1. Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline [ Time Frame: Assessment of QoL changes will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start as compared to baseline ]
    The change in QoL will be assessed as the difference in QoL means by scales of RAND SF-36 between any time-points during 18 mos of treatment and additionally as the difference in QoL means at any time-point as compared to baseline.

  2. Changes in symptom severity while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline [ Time Frame: Assessment of changes in symptom severity will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start ]
    The change in symptom severity will be assessed as the difference in the severity of each ESAS-R scale, the symptom distress score and the severity of NRS for assessing tingling hands/feet between any time-points during 18 mos of treatment and additionally at each time-point as compared with their baseline value. The proportion of patients with ≥1 point improvement on ESAS-R scale and on NRS for assessing tingling hands/feet at each time-point will be analyzed as well

  3. Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone [ Time Frame: Assessment will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start ]
    Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone will be assessed at each time-point during treatment with ixazomib in combination with lenalidomide and dexamethasone


Secondary Outcome Measures :
  1. Overall response rates and duration of response to treatment with ixazomib in combination with lenalidomide and dexamethasone [ Time Frame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone ]
    Response to treatment will be assessed within the study and derived using the IMWG 2011 (International Myeloma Working Group). Duration of response will be evaluated from the time of initial response to treatment with ixazomib in combination with lenalidomide and dexamethasone till the disease progression or death from any cause

  2. Progression free survival (PFS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone [ Time Frame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone ]
    PFS will be estimated from initiation of treatment with ixazomib in combination with lenalidomide and dexamethasone till the disease progression or death from any cause.

  3. Overall survival (OS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone [ Time Frame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone ]
    OS will be estimated from initiation of treatment with ixazomib in combination with lenalidomide and dexamethasone till death from any cause

  4. Frequency of adverse events (AEs)/serious AEs in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone [ Time Frame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone ]
    The analysis of safety of treatment with ixazomib in combination with lenalidomide and dexamethasone will include reporting adverse events (AEs)/serious AEs (SAEs). For adverse events assessment the NCI CTCAE v. 4.0 will be used. The incidence and severity of any AEs/SAEs will be evaluated within the study



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:   Non-Probability Sample
Study Population
Adult patients with RRMM, who have received at least one prior therapy and who are suitable for triple therapy with ixazomib in combination with lenalidomide and dexamethasone. The eligibility criteria for this study are broader than the eligibility of patients to be treated with ixazomib in randomized clinical trials, so as to be reflective of routine clinical practice
Criteria

Inclusion Criteria:

  • Adult patients with confirmed diagnosis of RRMM
  • At least 18 years of age at the time of treatment start
  • Patients who have received at least one prior therapy and who are suitable for treatment with ixazomib in combination with LenDex
  • Patients who gave informed consent
  • Patients who are capable to fill out questionnaires
  • Patients with expected life duration of at least 6 months

Exclusion Criteria:

  • Patients currently enrolled in any other clinical trials
  • Patients with contraindications to ixazomib in accordance with instruction for use.

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): NCT03903406


Contacts
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Contact: Tatiana Nikitina, PhD +79627101712 tnikitina_74@mail.ru

Sponsors and Collaborators
Multinational Center for Quality of Life Research, Russia

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Responsible Party: Multinational Center for Quality of Life Research, Russia
ClinicalTrials.gov Identifier: NCT03903406     History of Changes
Other Study ID Numbers: IISR-2018-102607
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Multinational Center for Quality of Life Research, Russia:
quality of life
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
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
Ixazomib
Glycine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal