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

Relapsed and/or Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03903406
• Other study ID #: IISR-2018-102607
• Status: Not yet recruiting
• Start date: May 2019
• Est. completion date: November 2021

Study information

• Verified date: April 2019
• Source: Multinational Center for Quality of Life Research, Russia
• Contact: Tatiana Nikitina, PhD
• Phone: +79627101712
• Email: tnikitina_74[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed and/or Refractory Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Multinational Center for Quality of Life Research, Russia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?hanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with 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.	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
Primary	Changes in symptom severity while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline	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	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
Primary	Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone	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	Assessment will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start
Secondary	Overall response rates and duration of response to 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	18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
Secondary	Progression free survival (PFS) in RRMM patients receiving 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.	18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
Secondary	Overall survival (OS) in RRMM patients receiving 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	18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
Secondary	Frequency of adverse events (AEs)/serious AEs in RRMM patients receiving 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	18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone