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Multiple Myeloma in RelapseEPC-MM+LNCT06485076

Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

A study testing Early Palliative Care in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Early Palliative Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteCanada
Study dates
18 Jul 2024to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years; (ii) A new diagnosis of multiple myeloma or at progression of disease necessitating a change in treatment plan, or relapsed/refractory aggressive B cell lymphoma after one prior line of therapy; (iii) Eastern Cooperative Oncology Group (ECOG) performance status 0-3; (iv) Willingness to complete symptom screening; and (v) At least one ESAS-r-plus symptom scored at ≥3 at time of recruitment.
  • Age ≥18 years; (ii) Caregiver of a patient with relapsed B cell lymphoma; and (iii) Willing to attend at least 1 PCC visit with the patient.
  • Specialized staff physician, fellow, clinical nurse specialist, or clinic nurse from the outpatient malignant hematology team or palliative care team at PM working clinically with patients with multiple myeloma; and (ii) Working in their clinical area for at least 12 months.

Who cannot join

  • Insufficient English literacy to complete study procedures; (ii) Hematologist-determined poor cognitive status; (iii) Current palliative care team involvement at PM or elsewhere; and (iv) Not receiving ongoing follow up with malignant hematology team at PM.
  • Caregiver eligibility criteria:
  • Insufficient verbal and/or written English literacy to complete study procedures; or (ii) Patient not participating in study.
  • Healthcare provider eligibility criteria:

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Breffni Hannon, MB BCh BAO, MMedSci, MCFP contact

416-946-4501 ext. 3261

Breffni.Hannon@uhn.ca

Canada1 site, 1 recruiting
  • Princess Margaret Cancer Centre

    Toronto, Ontario

    Breffni Hannon, MB BCh BAO, MMedSci, MCFP

    Recruiting

Other trials in Canada

About this study

Official title: Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life. Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden, mood, and quality of life in patients with solid tumours (e.g. lung, breast or gynecological cancers), but has not been explored among patients with blood cancers to date.

The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) attending the Princess Margaret Cancer Centre. The main goals of the study are:

Read more
  • To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only)
  • To see if this early palliative care intervention works well for these patients and caregivers
  • To compare patient and caregiver experiences with early palliative care and usual care
  • To explore perceptions and experiences of providing palliative care among healthcare providers involved in the care of these patients and caregivers.

Patients, and their respective caregivers if participating, will be randomly assigned to one of two groups: one group will receive early palliative care in addition to usual care from their blood cancer doctor, and the other group will receive usual care from their blood cancer doctor only. All participants will be asked to fill out questionnaires about their quality of life, symptom burden, mood, and satisfaction with care throughout the study. Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care and their caregivers.

Some patients and caregivers will be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study. Some healthcare providers who care for these patients will also be asked to take part in interviews at the end of the trial to describe their perceptions and experiences of providing palliative care.

The researchers will use the results of this study to guide in the development of a larger clinical trial.

Read the detailed description

In this study, the investigators will test an early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) in a randomized phase II trial in which outpatients and their caregivers will be allocated to one of two groups: symptom screening alone (usual care) or early palliative care alongside usual care (intervention).

Participants will be recruited from multiple myeloma and lymphoma outpatient clinics at the Princess Margaret Cancer Centre. Consenting patients and caregivers will complete questionnaires measuring outcomes of quality of life, symptom burden, depression, and satisfaction with care at recruitment, 1 month, 2 months, and 3 months. After the 3-month follow-up time point, select patients and caregivers will complete a one-time semi-structured interview that explores their experiences taking part in the study. Select healthcare providers from the multiple myeloma, lymphoma, and palliative care teams will also be invited to participate in a one-time focus group or individual interview. Healthcare providers in malignant hematology will be asked to describe their perceptions of palliative care and providers in palliative care will be asked to describe their experiences providing palliative care to patients with multiple myeloma and aggressive lymphoma and their caregivers.

The purposes of this phase II trial are to:

  1. Assess the feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only).
  2. Assess preliminary efficacy of early palliative care for these outpatients and caregivers.
  3. Qualitatively compare patient and caregiver experiences and perceptions of palliative care between the intervention and usual care arms of the study.
  4. Qualitatively describe perceptions of palliative care among healthcare providers in malignant hematology, as well as the experiences of providing palliative care to patients with multiple myeloma and aggressive lymphoma among healthcare providers in palliative care.

Feasibility criteria are: (i) accrual of at least 80 patients (40 with multiple myeloma and 40 with aggressive B cell lymphoma) and up to 40 caregivers of patients with aggressive B cell lymphoma over 12 months; (ii) ≥60% of recruited patients and caregivers complete self-reported outcomes (PROs) at baseline, and monthly for three months; and (iii) ≥60% of patients and their caregivers in the intervention arm have at least one visit to the palliative care clinic.

Being tested
Early Palliative Care
Keywords
early palliative care, multiple myeloma, quality of life, symptom management, aggressive lymphoma
Medical subject headings
Multiple Myeloma, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Palliative CareOther

    see previous description

Study groups in NCT06485076
Study groupRoleWhat they receive
Early Palliative CareExperimentalPatients in the intervention/early palliative care arm will be invited to attend a consultation (in-person or via Microsoft Teams) in the outpatient palliative care clinic alongside ongoing care from their hematologist. The intervention will comprise of a comprehensive interdisciplinary assessment from a specialist palliative care nurse and a physician within two weeks of referral and monthly follow-up visits (in-person, via Microsoft Teams, or via phone) for 3 months. This will include an assessment of physical symptoms, psychological distress, social supports and advance care planning, as well as 24/7 telephone support between visits, community-based resources, and access to the acute palliative care unit, if required. Caregivers of these patients will be encouraged to attend at least one palliative care clinic visit with the patient.
Receives: Other: Early Palliative Care
Usual CareNo interventionPatients in the usual care arm will receive care from their hematologist as usual, with referral to the outpatient palliative care clinic at the discretion of the hematologist or upon patient request

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only)

    The intervention will be feasible if the following criteria are met:

    (i) accrual of at least 80 patients (40 with multiple myeloma and 40 with aggressive B cell lymphoma) and up to 40 caregivers of patients with aggressive B cell lymphoma over 12 months; (ii) ≥60% of recruited patients and caregivers complete self-reported outcomes (PROs) at baseline, and monthly for three months; and (iii) ≥60% of patients and their caregivers in the intervention arm have at least one visit to the palliative care clinic.

    Measured: 12 months

  2. Patient quality of life as measured by the FACIT-Pal

    The FACIT-Pal (Functional Assessment of Chronic Illness Therapy-Palliative Care) quality of life scale is a version of the 27-item FACT-G (Functional Assessment of Cancer Therapy-General) scale, with the addition of 19 items for patients with advanced illness. These 46 items measure physical, social/family, emotional, functional well-being, and additional concerns. Total scores range from 0-184, with higher scores indicating better quality of life.

    Measured: 3 months after enrollment

Secondary outcomes (7)
  1. Patient quality of life as measured by the FACIT-Pal

    The FACIT-Pal (Functional Assessment of Chronic Illness Therapy-Palliative Care) quality of life scale is a version of the 27-item FACT-G (Functional Assessment of Cancer Therapy-General) scale, with the addition of 19 items for patients with advanced illness. These 46 items measure physical, social/family, emotional, functional well-being, and additional concerns. Total scores range from 0-184, with higher scores indicating better quality of life.

    Measured: 1 month and 2 months after enrollment

  2. Patient symptom control as measured by the ESAS-r-CS

    The ESAS-r-CS (Edmonton Symptom Assessment System-revised plus constipation and trouble sleeping) consists of 11 scales with anchors of 0 (best) and 10 (worst) with symptom descriptions for pain, fatigue, drowsiness, nausea, anxiety, depression, appetite, dyspnea, well-being. Individual symptom scores are summed for the ESAS Distress Score (9-items) and Total Distress Score (11-items). Individual scores range from 0-10, with lower scores indicating better symptom control.

    Measured: 1 month, 2 months, and 3 months after enrollment

  3. Patient and caregiver depression as measured by the PHQ-9

    The PHQ-9 (Patient Health Questionnaire-9 item version) is a measure for screening, diagnosing, and monitoring the severity of depression. Total scores range from 0-27, with higher scores indicating worse depression.

    Measured: 1 month, 2 months, and 3 months after enrollment

  4. Patient satisfaction with care as measured by the FAMCARE-P16

    The FAMCARE-P16 (FAMCARE satisfaction with care scale-16-item patient version) is a 16-item scale that measures patient satisfaction with information-giving, availability of care, psychological care and physical patient care in patients with advanced cancer. Total scores range from 16-80, with higher scores indicating greater satisfaction with care.

    Measured: 1 month, 2 months, and 3 months after enrollment

  5. Patient performance status as measured by the PRFS

    The PRFS (Patient-Reported Function Status) measures a patient's own activities and function on a five-point scale. It is based on the ECOG (Eastern Cooperative Oncology Group) performance scale, but is expressed in lay language. Total scores range from 0-4, with lower scores indicating better performance status.

    Measured: 1 month, 2 months, and 3 months after enrollment

  6. Caregiver quality of life as measured by the CQOLC

    The CQOLC (Caregiver Quality of Life Index-Cancer) is a 35-item measure of burden, disruptiveness, adaptation, financial, and additional caregiver concerns. Total scores range from 0-140, with higher scores indicating worse quality of life.

    Measured: 1 month, 2 months, and 3 months after enrollment

  7. Caregiver satisfaction with patient care as measured by the FAMCARE-caregiver

    The FAMCARE-caregiver is a 19-item caregiver version of the FAMCARE scale. Total scores range from 20-100, with higher scores indicating greater satisfaction with patient care.

    Measured: 1 month, 2 months, and 3 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start18 Jul 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485076
Sponsor's protocol ID
DeGasperis
Acronym
EPC-MM+L
Status last verified
Nov 2025
First submitted
25 Mar 2024
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Early Palliative Care in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Breffni Hannon, MB BCh BAO, MMedSci, MCFP (416-946-4501 ext. 3261, Breffni.Hannon@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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