The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma

April 16, 2026 updated by: Smith Giri, University of Alabama at Birmingham
Multiple Myeloma (MM) patients are prone to poor quality of life (QoL) as a result of the anxiety and depression they suffer due to a poor understanding of their disease. Improving patient understanding of their illness and addressing issues that induce distress impacts QoL. This prospective, interventional study is designed to see if a structured psycho-educational program called "the myeloma pack intervention" (MPI), implemented in parallel with standard cancer treatment, can improve QoL for patients with MM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this research study is to see if the MPI educational program, implemented in parallel with standard of care treatment, can improve overall quality of life (QoL) for MM patients. This program will be delivered to the study participants by multiple modes of communication including written material in a boxed pack, online tutorials, telephone and text message follow up. If they do not have online access at home, the study coordinators will arrange access for the participants at the Clinic. A health advisor will work with the physicians to coordinate their participation in the program while they are on active treatment for myeloma. The Pack Health Advisors will only give them guidance about the study and they will not provide any kind of clinical advice to the participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Of age ≥18 years or older.
  • Having a diagnosis of MM; newly diagnosed or relapsed/refractory disease
  • Undergoing systemic treatment through the UAB MM Clinic Pathway
  • Able to provide informed consent to be included in the intervention
  • MM patients in a prior/concurrent (non-pyscho/educational intervention), MM study will be eligible to participate
  • Have either SMS texting or email access to receive encouragement messages

Exclusion Criteria:

Patients will be ineligible for the program if they are:

  • Being treated by end-of-life or comfort care measures only
  • MM patients not treated through the UAB MM Clinic Pathway.
  • MM patients not requiring systemic therapy.
  • Patients with a diagnosis of MGUS or SMM.
  • Have a history of other malignancy within the past [3 or 5] years with the exception of:
  • Malignancies treated with curative intent and with no known active disease present for ≥ 3 (or 5) years before enrollment and felt to be at low risk for recurrence by the treating physician
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • Adequately treated breast ductal carcinoma in situ without evidence of disease
  • Prostatic intraepithelial neoplasia without evidence of prostate cancer
  • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
  • Are enrolled in a prior/concurrent MM psycho-educational study

Other Exclusions:

  • Patients who do not have either SMS texting or email access to receive encouragement messaging will be excluded
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARM A EARLY INTERVENTION GROUP
In Arm A, the intervention group, the participants will start on the program immediately. The participants will receive MPI educational program, implemented in parallel with standard of care treatment. The MPI is implemented at the time of enrollment x 12 weeks
Other: ARM A EARLY INTERVENTION GROUP

Post randomization, all patients will take baseline survey to assess their level of stress prior to starting the educational program During the educational interventions they will receive

  • 1 video/picture/worksheet per week covering the topic to be covered.
  • 1 phone/week by the Health Advisor, to discuss the topic for the week s/as their disease, stress and anxiety management, life organization, adherence skills, healthy eating and sleeping). Participant and the health advisor will also set up a "Tiny Step"" to serve as a goal for the week .
  • 3 emails/texts through the week, to remind about the topic covered, or to encourage them on their Tiny Step goal.

After 12 weeks on the program participants will re-take the surveys to assess the level of stress.
Experimental: ARM B DELAYED INTERVENTION GROUP
Arm B, is a wait-list control group that will serve as the control. The wait-list control group will be observed for an initial 12 week period while receiving usual care and then have the educational intervention implemented from week 12-24 in parallel with standard of care
Other: ARM B DELAYED INTERVENTION GROUP
The educational intervention is similar as in ARM A except that the participants will receive standard of care for the first 12 weeks post randomization and then begin the educational intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Time Frame: Baseline
We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Baseline
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Time Frame: 12 weeks post intervention
We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
12 weeks post intervention
Assess anxiety levels 24 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
Time Frame: 24 weeks post intervention
We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
24 weeks post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
Time Frame: Baseline
We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression
Baseline
Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
Time Frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression
12 weeks post intervention
Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
Time Frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression
24 weeks post intervention
Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
Time Frame: Baseline
We will assess baseline patient self-efficacy for symptom management in MM patients before the implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Baseline
Assess patient self-efficacy for symptom management 12 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
Time Frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
12 weeks post intervention
Assess patient self-efficacy for symptom management 24 weeks after educational program (MPI) in MM patients using the PROMIS assessment tool for self-Efficacy
Time Frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
24 weeks post intervention
Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index
Time Frame: Baseline
We will baseline assess patient adherence to myeloma specific medication and treatment schedules in MM patients before the implementation of educational program (MPI) using the CASE Medication Adherence Index
Baseline
Assess patient improvement in adherence to myeloma specific medication and treatment schedules 12 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index
Time Frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
12 weeks post intervention
Assess patient improvement in adherence to myeloma specific medication and treatment schedules 24 weeks after educational program (MPI) in MM patients using the CASE Medication Adherence Index
Time Frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
24 weeks post intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess baseline Qualityof Life (QoL) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time Frame: Baseline
We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Baseline
Assess effect on Qualityof Life (QoL) 12 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time Frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
12 weeks post intervention
Assess effect on Qualityof Life (QoL) 24 weeks after educational program (MPI) in MM patients undergoing therapy using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time Frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
24 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PackHealth/Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Smith Giri, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300000121
  • PackHealth/Amgen (Other Identifier: PackHealth/Amgen)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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