What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as lenalidomide, dexamethasone, bortezomib, and daratumumab, have several known side effects. Lenalidomide and dexamethasone can cause infections, venous thromboembolism, and cataracts. Bortezomib is associated with thrombocytopenia, neutropenia, lymphopenia, peripheral sensory neuropathy, and gastrointestinal issues like diarrhea and constipation. Daratumumab can lead to infusion reactions, respiratory infections, and fatigue. These side effects highlight the importance of monitoring and managing adverse effects during treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including bortezomib, lenalidomide, and dexamethasone, which are often used in combination regimens. For instance, the combination of lenalidomide and dexamethasone (Rd) is commonly used, with adjustments such as reduced-dose lenalidomide for maintenance therapy. Additionally, ixazomib, an oral proteasome inhibitor, is approved for use with lenalidomide and dexamethasone (IRd) for patients who have received at least one prior therapy. These treatments aim to improve progression-free survival and overall survival while managing toxicity. Exercise interventions, like the Telehealth Exercise Program, are being studied to further enhance physical function and reduce frailty in Multiple Myeloma survivors.

What other types of research exist?

Promising alternatives to a Telehealth Exercise Program for Multiple Myeloma patients include: 1) Supervised, clinic-based multi-component exercise programs, which have shown improvements in VO2max, strength, lean body mass, and quality of life in advanced cancer patients. 2) Home-based aerobic exercise programs, which have been piloted successfully in hematopoietic stem cell transplant recipients, improving aerobic fitness and reducing fatigue. Both alternatives emphasize structured, supervised exercise tailored to the patient's condition and capabilities.

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Telehealth Exercise for Multiple Myeloma

N/A

Waitlist Available

Led By Kyuwan Lee

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has undergone autologous stem cell transplant (ASCT) within 30 and 180 days prior to registration

>= 18 years old

Must not have

Female patients who are pregnant or planning to become pregnant

Have clinically significant/active cardiovascular disease (e.g. unstable angina, uncontrolled arrhythmia, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a telehealth exercise program for multiple myeloma survivors. The program uses videos to guide patients through various exercises to improve their strength and physical function. The goal is to help these patients feel stronger and less frail by engaging in regular physical activity.

Who is the study for?

This trial is for adults diagnosed with multiple myeloma who are pre-frail or frail, have had a stem cell transplant within the last 30-180 days, and can perform study tasks. They must not have serious heart issues, exercise contraindications like infections or unstable bone lesions, recent injuries affecting exercise ability, or be doing regular intense exercise.

What is being tested?

The study tests a telehealth-based exercise program aimed at improving physical function and reducing frailty in multiple myeloma survivors. Participants will follow online videos for exercises focusing on coordination, posture, stretching, balance, and resistance/cardio training.

What are the potential side effects?

Since this intervention involves an exercise program delivered via telehealth without medications involved, side effects may include typical workout-related discomforts such as muscle soreness or strain but should generally be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stem cell transplant using my own cells between 1 to 6 months ago.

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I am 18 years old or older.

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I have been diagnosed with multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant or planning to become pregnant.

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I do not have any serious heart conditions like unstable chest pain or uncontrolled irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Physical function

Secondary study objectives

Frailty index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (home-based exercise program)Experimental Treatment3 Interventions

Patients undergo home-based exercise program 3 times per week for 8 weeks. Patients complete questionnaires at baseline (before 1 week) and at weeks 9 and 17.

Group II: Arm B (current activities)Active Control3 Interventions

Patients complete questionnaires at baseline and at week 9 and 17. Patients continue maintaining current activities of daily living and do not participate in any exercise program. Patients may then participate in home-based exercise program 3 times per week for 8 weeks.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and corticosteroids (e.g., dexamethasone). Proteasome inhibitors work by blocking the proteasome's function, leading to the accumulation of proteins within cancer cells, which induces cell death. Immunomodulatory drugs enhance the immune system's ability to attack cancer cells and inhibit their growth. Corticosteroids help reduce inflammation and kill myeloma cells. These treatments are crucial for Multiple Myeloma patients as they directly target the cancer cells, manage symptoms, and improve overall survival. Additionally, exercise interventions, such as those studied in the Telehealth Exercise Program, can improve physical function and reduce frailty, enhancing the quality of life for patients.

Nutritional and Exercise Interventions in Cancer-Related Cachexia: An Extensive Narrative Review.Exercise for cancer cachexia in adults.Feasibility of implementing an exercise intervention in older adults with hematologic malignancy.