Early Palliative Care for Multiple Myeloma and Lymphoma

(EPC-MM+L Trial)

Overseen By Breffni Hannon, MB BCh BAO, MMedSci, MCFP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Poor English literacy, Poor cognitive status, Current palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early palliative care can enhance the well-being of people with multiple myeloma or aggressive B cell lymphoma. Palliative care focuses on relieving symptoms and stress to improve quality of life. Participants will either receive early palliative care alongside their regular cancer treatment or continue with their usual care. The trial seeks individuals newly diagnosed with multiple myeloma or those with aggressive B cell lymphoma who have experienced a change in treatment plan. Researchers aim to determine if early palliative care reduces symptoms and improves mood and satisfaction compared to regular care alone. As an unphased trial, this study provides a unique opportunity to understand the benefits of early palliative care in enhancing quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual cancer care, but it's best to confirm with the trial coordinators.

What prior data suggests that this early palliative care intervention is safe for patients with multiple myeloma and aggressive lymphoma?

Research has shown that starting palliative care early is safe for patients, including those with blood cancers like multiple myeloma and aggressive lymphomas. Studies have found that this care helps manage symptoms such as pain and improves overall quality of life. Patients generally handle early palliative care well, with no major safety concerns reported. This care includes regular check-ins with a team of specialists to address both physical and emotional needs. So far, patients with blood cancers have responded positively, experiencing relief from symptoms and improved quality of life without significant issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early palliative care for multiple myeloma and lymphoma because it offers a comprehensive, interdisciplinary approach that goes beyond typical care. Unlike standard treatments that focus solely on the disease itself, early palliative care integrates physical, psychological, and social support, addressing the broader needs of the patient. This approach provides continuous support with regular follow-ups and 24/7 access to resources, which can significantly improve the quality of life for patients. By involving both a specialist palliative care nurse and a physician, it ensures a holistic assessment and tailored care plan from the very beginning, potentially leading to better overall outcomes.

What evidence suggests that early palliative care is effective for multiple myeloma and lymphoma?

Research shows that starting palliative care early can improve cancer patients' well-being. In this trial, participants in the early palliative care arm will receive comprehensive support, including physical symptom assessment, psychological support, and advance care planning. Studies have found that patients with multiple myeloma who receive early palliative care experience better pain and symptom control. They also report greater happiness and an improved quality of life. While most research has focused on patients with solid tumors, the benefits suggest it could also aid those with blood cancers like multiple myeloma and aggressive lymphomas. These improvements make early palliative care a promising option for managing symptoms and enhancing overall well-being. ^{2 3 6 7 8}

Who Is on the Research Team?

Breffni Hannon, MB BCh BAO, MMedSci, MCFP

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

This trial is for patients with multiple myeloma or aggressive B-cell lymphoma. It's designed to see if early palliative care, alongside standard cancer treatment, can improve their well-being and quality of life.

Inclusion Criteria

Willingness to complete symptom screening

I have a new or worsening multiple myeloma or aggressive B cell lymphoma after one treatment.

I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

Insufficient English literacy to complete study procedures

Failure to score a single item at ≥3 of the ESAS-r-plus at time of recruitment

Hematologist-determined poor cognitive status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Palliative Care Intervention

Participants receive a comprehensive interdisciplinary assessment and monthly follow-up visits for 3 months, including 24/7 telephone support and access to community-based resources.

3 months

1 initial consultation (in-person or virtual), monthly follow-up visits

Follow-up

Participants are monitored for outcomes such as quality of life, symptom burden, and satisfaction with care.

3 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Early Palliative Care

Trial Overview

The study tests whether introducing early palliative care improves outcomes like symptom management and mood compared to usual cancer care alone. Participants are randomly assigned to receive either additional early palliative care or just the standard treatment.

How Is the Trial Designed?

Group I: Early Palliative Care Experimental Treatment 1 Intervention

Patients 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.

Group II: Usual Care Active Control 1 Intervention

Patients 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Myeloma Canada

Collaborator

Trials

2

Recruited

640+

The Leukemia and Lymphoma Society of Canada

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

Patients with multiple myeloma receiving early palliative care (EPC) showed significantly better quality of care indicators compared to those receiving usual hematological care (UHC), with an average of 2.62 indicators versus 1.12 (p<0.0001).

EPC patients experienced a significant reduction in pain intensity over time and demonstrated a trend towards less aggressive end-of-life care, while having similar survival rates compared to UHC patients (5.3 vs 5.46 years; p=0.74).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative care versus usual haematological care in multiple myeloma: retrospective cohort study. Giusti, D., Colaci, E., Pioli, V., et al.[2023]

In a 10-year study of 26 multiple myeloma patients in the Niger-Delta region, most presented with advanced disease (61.5% in stage III) and experienced severe complications like bone pain (84.6%) and anemia (61.5%), highlighting the need for earlier diagnosis and better palliative care.

Only 7.6% of patients survived up to 5 years post-diagnosis, with a mean survival of 39.7 months, indicating that late diagnosis and inadequate palliative interventions significantly contribute to poor outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple myeloma in Niger Delta, Nigeria: complications and the outcome of palliative interventions. Nwabuko, OC., Igbigbi, EE., Chukwuonye, II., et al.[2020]

Recent studies have shown that high-cutoff hemodialysis can effectively remove free light chains in patients with renal disease related to multiple myeloma, improving their kidney function.

Updated guidelines recommend the use of levofloxacin to prevent infections and suggest effective management strategies for bone disease and anemia, which are crucial for enhancing the quality of life in myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care in Multiple Myeloma. Guzdar, A., Costello, C.[2020]

Among 5095 patients with multiple myeloma analyzed from 2006 to 2018, a significant majority (65.4%) received supportive care at the end of life, indicating a shift towards more compassionate care options.

Despite improvements in supportive care over the years, disparities still exist, with older patients and those from lower-income neighborhoods less likely to receive adequate supportive care, highlighting ongoing challenges in end-of-life treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of end-of-life care in multiple myeloma: A 13-year analysis of a population-based cohort in Ontario, Canada. Mohyuddin, GR., Sinnarajah, A., Gayowsky, A., et al.[2022]

Out of 456 deceased multiple myeloma patients studied, only 45.4% received specialist palliative care (SPC) during their illness, indicating low rates of SPC involvement in managing end-of-life care.

There was no significant correlation between receiving outpatient SPC and a reduction in deaths occurring in acute care settings, suggesting that SPC may not have effectively decreased aggressive end-of-life treatments for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care utilization, transfusion burden, and end-of-life care for patients with multiple myeloma. McInturf, G., Younger, K., Sanchez, C., et al.[2022]

A meta-analysis of 12 randomized controlled trials involving 2980 advanced cancer patients found that early palliative care significantly improves quality of life (QoL) both within 3 months and after 3 months compared to usual care.

Patients receiving early palliative care also experienced a notable reduction in symptom intensity and improved functional well-being, suggesting that this approach offers substantial clinical benefits over standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Early Palliative Care in Advanced Cancer Patients: A Meta-Analysis. Shih, HH., Chang, HJ., Huang, TW.[2022]

Patients and caregivers in a study of early palliative care alongside standard oncology care viewed the roles of oncologists and palliative care physicians as distinct yet complementary, enhancing overall cancer care.

The study suggests that integrating early palliative care into oncology can improve patient experiences by providing holistic symptom management alongside disease-focused treatment, advocating for more ambulatory palliative care clinics and timely referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Palliative Care and Its Role in Oncology: A Qualitative Study. Hannon, B., Swami, N., Pope, A., et al.[2022]

In a study of 119 older patients with multiple myeloma, 63% were hospitalized in their last month of life, and 64% continued to receive aggressive antimyeloma treatments, indicating a high level of intervention even at the end-of-life stage.

Only 20% of patients received palliative care referrals, highlighting a significant gap in support for managing pain and other symptoms, suggesting a need for better collaboration between palliative care teams and hematologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective review of end-of-life care in the last month of life in older patients with multiple myeloma: what collaboration between haematologists and palliative care teams? Chalopin, T., Vallet, N., Benboubker, L., et al.[2020]

Early palliative care (EPC) significantly improves the quality of life (QoL) for patients with advanced cancer, based on a systematic review of 12 randomized controlled trials involving various interventions.

While EPC shows positive effects on QoL, it does not significantly impact mood or symptom control, indicating that further research is needed to optimize these interventions and determine the best timing for their implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Early Palliative Care to Improve Quality of Life of Advanced Cancer Patients: A Meta-Analysis of Randomised Controlled Trials. Gautama, MSN., Damayanti, A., Khusnia, AF.[2023]

In a study of 238 multiple myeloma patients, researchers identified four distinct health-related quality of life trajectories, with two classes showing stable poor or declining quality of life over an 8-month period.

Key predictors of declining quality of life included high general symptom levels, clinically relevant anxiety, and pain, suggesting that early palliative care should focus on these patient-reported symptoms and psychosocial factors to identify those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms and anxiety predict declining health-related quality of life in multiple myeloma: A prospective, multi-centre longitudinal study. Ramsenthaler, C., Gao, W., Siegert, RJ., et al.[2020]

Early palliative care, recommended in international guidelines, significantly improves patients' quality of life and reduces symptom burden, as confirmed by a meta-analysis of seven randomized studies.

There is a trend indicating that early palliative care may also reduce depressive disorders and potentially increase overall survival, while benefiting patients' relatives and decreasing aggressive end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early palliative care in oncology]. Bouleuc, C., Burnod, A., Angellier, E., et al.[2019]

The EMPOWER 2 intervention, developed with input from 21 stakeholders and tested with 10 patients, effectively increased knowledge about palliative care by 83.1% and improved attitudes towards it by 18.9 points, indicating its potential to enhance patient readiness for palliative care.

The intervention was highly acceptable to stakeholders (3.78/4.00) and successfully met feasibility criteria, enrolling 10 patients within 14 days with an 83.3% consent rate, suggesting it can be implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Readiness for Early Integrated Palliative Oncology Care: Development and Initial Evaluation of the EMPOWER 2 Intervention. Perry, LM., Sartor, O., Malhotra, S., et al.[2022]

Citations

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In conclusion, our results suggest that EPC is feasible in patients with MM and results in better quality of care, including better management of pain, more ...

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Early palliative care in hematologic malignancies improves symptoms and quality of life, while reducing hospitalizations, transfusions, and chemotherapy near ...