CLINICAL TRIAL

Treatment for Multiple Myeloma

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Houston, TX

Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab

See full description

About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Refractory Multiple Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 2 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18 or older
Diagnosis of relapsed/refractory multiple myeloma corresponding to the Food and Drug Administration (FDA) package insert for isatuximab-irfc (Sarclisa®).
Confirmed or planned treatment with intravenous isatuximab-irfc for relapsed/refractory multiple myeloma as standard-of-care therapy. Concurrent therapy with other agents (e.g., pomalidomide) is allowed.
Access to and willingness to use a smartphone or other device through which they can send and receive text messages, emails and/or access a mobile application.
Willingness to wear and have data collected by a Fitbit
Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From date of enrollment up to 3 months
Screening: ~3 weeks
Treatment: Varies
Reporting: From date of enrollment up to 3 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From date of enrollment up to 3 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes, 8 secondary outcomes, and 3 other outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Change in baseline perception of treatment experience at 3 months.

Change in Cancer Behavior Inventory-Brief Form (CBI-B)
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
The Center for Adherence Support Evaluation (CASE) is a three-item questionnaire used to measure antiretroviral therapy adherence. This questionnaire was developed through the Special Projects of National Significance (SPNS) initiative called Assessing Existing Efforts to Increase Adherence to Medication. Patients take less than 5 minutes to answer the three unique questions, asking about their difficulty taking medications on time, average days per week with one dose missed, and the last time they missed a dose.
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
Change in Patient Global Impression of Change (PGIC) Scale
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
A 1-item measure of patient perception of change in relapsed/refractory multiple myeloma symptoms since starting a study. Responses are scored on a 7-point scale, ranging from "very much worse" to "very much better".
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
Change in European QoL-5 Dimensions (EQ5D)
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
A measure of quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
Change in Patient Global Impression of Severity (PGIS) Scale
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
A 1-item measure of severity of relapsed/refractory multiple myeloma symptoms since the last visit, which is scored a on a 5-response scale ranging from "none" to "very severe".
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.
CHANGE IN BASELINE PERCEPTION OF TREATMENT EXPERIENCE AT 3 MONTHS
See More

Patient Q & A Section

Ask a question about the study

Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Multiple Myeloma by sharing your contact details with the study coordinator.