Palliative Care for Multiple Myeloma

Overseen By Renato Samala, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Prior palliative care, Hospice transition

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how early palliative care might improve the quality of life for people newly diagnosed with multiple myeloma, a type of cancer affecting blood cells. Palliative care, also known as supportive care, end-of-life care, or symptom management, focuses on easing symptoms like pain, tiredness, and sadness, which often trouble those with this condition. Participants will receive palliative care alongside their regular treatment for one year. The trial seeks individuals diagnosed with multiple myeloma in the last eight weeks who are receiving treatment at a Cleveland Clinic facility. As an unphased trial, this study offers a unique opportunity to enhance quality of life while contributing to important research.

What prior data suggests that palliative care is safe for multiple myeloma patients?

Research shows that palliative care is safe for people with multiple myeloma, a type of blood cancer. Studies have found that adding palliative care, which focuses on comfort and quality of life, helps manage symptoms like pain and tiredness. This care improves mood and overall well-being. No evidence indicates any serious side effects from palliative care itself, and patients generally tolerate it well. Previous studies have not reported significant negative effects linked to palliative care in multiple myeloma patients, suggesting it is a safe option alongside regular cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early palliative care integration for multiple myeloma because it focuses on enhancing quality of life alongside standard treatments. Unlike traditional approaches that primarily target the disease itself, this method emphasizes symptom management and emotional support right from the start of treatment. By integrating palliative care early, the approach aims to address pain, fatigue, and other symptoms more effectively, potentially leading to improved overall well-being and patient satisfaction throughout the treatment journey.

What evidence suggests that early palliative care is effective for improving quality of life in multiple myeloma patients?

Research shows that starting palliative care (PC) early can greatly benefit people with multiple myeloma (MM). In this trial, participants will receive early PC integration alongside their standard MM treatment. Studies have found that early PC addition improves patient outcomes, such as reducing symptoms, lifting mood, and enhancing overall quality of life. Specifically, patients who received early PC reported better control of symptoms like pain and fatigue. These improvements help patients cope more effectively with the challenges of MM treatment and daily life. Although MM cannot be cured, this approach helps patients live more comfortably with their condition. ^{2 6 7 8 9}

Who Is on the Research Team?

Renato Samala, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals recently diagnosed with symptomatic Multiple Myeloma, within eight weeks. They should be able to perform daily activities with varying degrees of assistance (ECOG status 0-3) and must be receiving care at a Cleveland Clinic facility. Those who have already seen a Palliative Care provider or require immediate hospice care cannot participate.

Inclusion Criteria

Able to read and respond to questions in English

You are currently getting cancer treatment at a Cleveland Clinic facility.

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

Exclusion Criteria

Have seen a PC provider in any setting (i.e., inpatient, outpatient or home-based)

I need to be referred to palliative care for end-of-life care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Palliative Care Integration

Participants meet with a member of the outpatient PC team within three weeks of enrollment

3 weeks

1 visit (in-person)

Ongoing Palliative Care and Standard Treatment

Participants receive 12 months of palliative care with concurrent standard treatment for MM, including QOL assessments

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Palliative Care

Trial Overview The study is examining the impact of early Palliative Care on quality of life for new Multiple Myeloma patients. It involves assessing symptom relief and well-being using specific questionnaires like FACT-MM and HADS during the treatment process.

How Is the Trial Designed?

Group I: Early Palliative Care Integration Experimental Treatment 3 Interventions

12 months of PC with concurrent standard treatment for MM, QOL assessments

Palliative Care is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Approved in United States as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Approved in Canada as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176925/

Integrating palliative care into multiple myeloma ... Patient survival after discharge from the PCU varied, with 45% of patients dying in the hospital and the remaining 55% having a median overall survival of 1.4 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.7563

Access to palliative care in patients with multiple myeloma ... This study explores potential associations between race, ethnicity, socioeconomic factors, and PC access for MM patients in the USA.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06485076

Early Palliative Care for Patients With Multiple Myeloma ... 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 ...

4. hematologyadvisor.com hematologyadvisor.com/news/multiple-myeloma-palliative-approach-care-untapped-benefit-patients/

Palliative Approach to Care an Untapped Benefit for ... Palliative approach to care (PC) can offer many benefits to patients with multiple myeloma (MM), but more research is needed to determine how it ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8795014/

Patients with multiple myeloma referred for palliative care ... The median time lapse between MM diagnosis and first PC visit was 355 days, quite early considering that MM has a median survival of 7 years.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39342520/

Integrating palliative care into multiple myeloma ... Methods: This retrospective single-center study examines the outcome of 22 MM patients admitted to the Division of Palliative Medicine at the ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124106878

Association of Palliative Care Involvement and Infectious ... Pain is the most common symptom in multiple myeloma (MM), and palliative care (PC) involvement often focuses on symptom management.

8. bloodcancerstoday.com bloodcancerstoday.com/post/factors-associated-with-palliative-care-use-among-patients-with-multiple-myeloma

Palliative Care Use Among Patients with Multiple Myeloma The study found that patients with MM aged 70 years and older had 1.30 times higher odds (95% confidence interval [CI], 1.20-1.42) of receiving ...

9. ajmc.com ajmc.com/view/end-of-life-care-in-multiple-myeloma-still-requires-fine-tuning-despite-improvements

End-of-Life Care in Multiple Myeloma Still Requires Fine- ... Overall, patients who died within 180 of receiving their MM diagnosis were less likely to receive palliative care within 30 days of death ...