Multiple MyelomaNCT03777306
The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma
A study testing ARM A EARLY INTERVENTION GROUP and ARM B DELAYED INTERVENTION GROUP in people with Multiple Myeloma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- ARM A EARLY INTERVENTION GROUP and ARM B DELAYED INTERVENTION GROUP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- ARM A EARLY INTERVENTION GROUP, ARM B DELAYED INTERVENTION GROUP
- Keywords
- Educational intervention
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARM A EARLY INTERVENTION GROUPOther
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.
ARM B DELAYED INTERVENTION GROUPOther
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
| Study group | Role | What they receive |
|---|---|---|
| ARM A EARLY INTERVENTION GROUP | Experimental | 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 Receives: Other: ARM A EARLY INTERVENTION GROUP |
| ARM B DELAYED INTERVENTION GROUP | Experimental | 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 Receives: Other: ARM B DELAYED INTERVENTION GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Measured: Baseline
Assess anxiety levels 12 weeks after educational program (MPI) in MM patients undergoing therapy using the PROMIS assessment tool for anxiety
We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Measured: 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
We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Measured: 24 weeks post intervention
Secondary outcomes (9)
Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression
Measured: Baseline
Assess depression levels 12 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression
Measured: 12 weeks post intervention
Assess depression levels 24 weeks after education intervention (MPI) in MM patients using the PROMIS assessment tool for depression
We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression
Measured: 24 weeks post intervention
Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
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
Measured: 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
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Measured: 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
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Measured: 24 weeks post intervention
Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index
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
Measured: 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
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Measured: 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
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Measured: 24 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start27 Nov 2017
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- PackHealth/Amgen
- Responsible party
- Principal investigator, Smith Giri, University of Alabama at Birmingham
- Investigators
- Smith Giri, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777306
- Sponsor's protocol ID
- IRB-300000121
- Other IDs
- PackHealth/Amgen
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2018
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Myeloma Pack: A Multi-Modality Educational Intervention Strategy to Engage Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03777306
- Acronym / sponsor ID
- IRB-300000121
- Conditions
- Multiple Myeloma
- Keywords
- Educational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- PackHealth/Amgen
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-modality didactic education program implemented in parallel to standard cancer treatment to improve QoL for patients with MM
| Arm | Type | Receives |
|---|---|---|
| ARM A EARLY INTERVENTION GROUP | Experimental | Other: ARM A EARLY INTERVENTION GROUPIn 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 |
| ARM B DELAYED INTERVENTION GROUP | Experimental | Other: ARM B DELAYED INTERVENTION GROUPArm 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARM A EARLY INTERVENTION GROUPPost 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. | Other | ARM A EARLY INTERVENTION GROUP |
| ARM B DELAYED INTERVENTION GROUPThe 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 | Other | ARM B DELAYED INTERVENTION GROUP |
Primary outcome
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
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
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
9 secondary outcomes
Assess baseline depression levels in MM patients using the PROMIS assessment tool for depression
Time frame: 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
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
Assess baseline patient self-efficacy for symptom management in MM patients using the PROMIS assessment tool for self-Efficacy
Time frame: 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
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
Assess baseline patient adherence to myeloma specific medication and treatment schedules in MM patients using the CASE Medication Adherence Index
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Smith Giri, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARM A EARLY INTERVENTION GROUP and ARM B DELAYED INTERVENTION GROUP in people with Multiple Myeloma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess baseline anxiety levels in MM patients undergoing therapy using the PROMIS assessment tool for anxiety (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.