What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma include chemotherapy, corticosteroids, immunomodulatory drugs, and proteasome inhibitors, which can cause side effects such as nausea, fatigue, infections, and neuropathy. Non-pharmacologic treatments like Mindfulness Awareness Practices for Insomnia, which promote relaxation and reduce stress, generally have minimal side effects. These practices may occasionally cause mild discomfort or emotional distress as patients confront stressors, but they are typically well-tolerated and can improve overall well-being and sleep quality.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Myeloma include a range of medications such as immunomodulatory drugs (e.g., lenalidomide, pomalidomide), proteasome inhibitors (e.g., bortezomib, carfilzomib), and monoclonal antibodies (e.g., daratumumab, elotuzumab). While these drugs target the cancer directly, integrative therapies like mindfulness and relaxation techniques, which are being studied in trials like Mindfulness Awareness Practices for Insomnia (MAP-I), can complement these treatments by improving sleep quality, reducing stress, and enhancing overall quality of life for patients.

What other types of research exist?

Promising alternatives to Mindfulness Awareness Practices for Insomnia for Multiple Myeloma patients include Cognitive Behavioral Therapy for Insomnia (CBT-I), which has strong evidence for improving sleep quality and reducing insomnia. Additionally, guided imagery and progressive muscle relaxation have shown effectiveness in reducing stress and improving sleep in cancer patients. Yoga and Tai Chi are also viable options, as they promote relaxation and have been associated with improved sleep quality in various patient populations.

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Behavioral Intervention

Mindfulness for Insomnia in Multiple Myeloma Patients

N/A

Waitlist Available

Led By Jennifer Knight, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Patient should be eligible to receive melphalan 200 mg/m2 as conditioning regimen

Karnofsky Performance Score (KPS) ≥70

Must not have

Prior autologous HCT

Outpatient HCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days after transplant procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if mindfulness exercises can help patients with multiple myeloma who are getting a specific type of cell transplant to sleep better. The study will compare these exercises to regular sleep health education.

Who is the study for?

This trial is for adults over 18 with multiple myeloma who haven't had a relapse or progression before hematopoietic cell transplant (HCT), can attend outpatient sessions, and are okay with surveys and blood draws. They must have started anti-myeloma therapy within the last year, be physically well enough to undergo a specific chemo regimen, and have an adequate stem cell graft. Those with prior HCTs, outpatient HCTs, amyloidosis, or known sleep apnea cannot join.

What is being tested?

The study compares Mindfulness Awareness Practices for Insomnia (MAP-I) against sleep health education in patients undergoing autologous HCT for multiple myeloma. It's randomized: participants don't choose which group they're in but are assigned by chance to either learn mindfulness techniques aimed at improving sleep or receive educational information about good sleep practices.

What are the potential side effects?

Potential side effects from MAP-I may include temporary discomfort like anxiety during practice or frustration if immediate improvements in sleep aren't seen. Sleep health education should not cause any direct side effects.

Eligibility Criteria

Inclusion Criteria

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

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I can receive a high-dose chemotherapy treatment.

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I am able to care for myself but may not be able to do active work.

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My stem cell graft has enough CD34+ cells for a transplant.

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I can attend the outpatient treatment sessions.

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My myeloma has not worsened or returned before stem cell transplant.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had a stem cell transplant using my own cells.

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I am receiving stem cell transplant treatments as an outpatient.

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I have been diagnosed with amyloidosis alongside my primary condition.

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I have been diagnosed with Obstructive Sleep Apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days after transplant procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 days after transplant procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days after transplant procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Completing Study Procedures

Number of Participants Enrolling in the Study

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: Mindfulness Awareness Practices for InsomniaExperimental Treatment1 Intervention

Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with 5 minutes and increasing to 20 minutes over the course of the 6-week intervention - as is standard with the Mindfulness Awareness Practices (MAPs) course - with practice prior to bedtime. An intervention training manual is the cornerstone of standardized delivery of MAP-I. Participants are also provided with a book on mindfulness (Fully Present: The Science, Art, and Practice of Mindfulness, authored by the Mindfulness Awareness Research Center (MARC) leader and MAP-I instructor Diana Winston) as well as access to the University of California Los Angeles (UCLA) Mindful App courtesy of the MARC at UCLA (via personal iPhone or study-administered tablets per patient preference), which contains pre-recorded guided meditations for use in daily practice.

Group II: Sleep Health EducationActive Control1 Intervention

Six individual 1-hour videos will be shown to participants at the same time points as, and with equal duration to, the MAP-I intervention. These videos will be recorded presentations that have been modified for HCT recipients based upon similar SHE interventions delivered in prior studies. Similar to the intervention group, patients in the SHE group will also participate in group Zoom chat sessions with equal frequency and duration lead by a study research coordinator. These sessions will allow for general patient interaction to discuss sleep and any questions or comments they may have, as lead by the group facilitator.

0 / 10Eligibility 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 chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cancer cells, while immunotherapy boosts the body's immune system to better attack cancer cells. Targeted therapy focuses on specific molecules involved in the growth and survival of cancer cells. Non-pharmacologic treatments, such as Mindfulness Awareness Practices (MAP), promote relaxation and reduce stress, which can improve sleep quality and reduce insomnia. These approaches are crucial for Multiple Myeloma patients as they not only target the cancer directly but also enhance overall well-being and potentially improve the effectiveness of medical treatments.