Multiple MyelomaNCT06126341
A Study to Identify Barriers to Cellular Therapies for People With Plasma Cell Disorders
An observational study of Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
This is an observational study that will include both participants with relapsed/refractory Multiple Myeloma and their doctors. The purpose of this study is to gather information about the use of hematopoietic cell transplantation/HCT and B-cell maturation antigen /BCMS targeted chimeric antigen receptor/CAR… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM, Hospital Anxiety and Depression Scale and Duke-UNC Functional Social Support Questionnaire
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Nov 2023to 3 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential participants contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigator may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study.
Who may be able to join
- Patient
- Diagnosis of Multiple Myeloma after January 1, 2017.
- Karnofsky Performance Status > 70%
- ≥ 2 lines of prior therapy
- Anticipated to start new a line of therapy for RRMM within the next 12 months
- Age 18-80 years of age.
Show all 12Show fewer
- English or Spanish speaking.
- Willing to provide informed consent
- Willing to perform study procedures.
- Physician Investigator
- Be a Co-Investigator
- Agree to comply with study procedures
Who cannot join
- Patient
- Active CNS disease
- Patients who already have a definitive plan are to be excluded
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Hartford Healthcare Alliance
Hartford, Connecticut, 06102
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Prospective Multi-Center Study to Identify Barriers to Cellular Therapies in Patients With Plasma Cell Disorders PROACT PCD
This is an observational study that will include both participants with relapsed/refractory Multiple Myeloma and their doctors. The purpose of this study is to gather information about the use of hematopoietic cell transplantation/HCT and B-cell maturation antigen /BCMS targeted chimeric antigen receptor/CAR autologous T-cell therapy.
- Conditions
- Multiple Myeloma
- Being tested
- Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM, Hospital Anxiety and Depression Scale, Duke-UNC Functional Social Support Questionnaire, Distress Thermometer, FACT-BMT
- Keywords
- Multiple Myeloma, BCMA CAR T-cell therapy, HCT, Memorial Sloan Kettering Cancer Center, 23-166
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMMOther
Physician investigators will review a lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM that discusses current information in regards to available cellular therapies in RRMM and a proposed treatment algorithm.
Hospital Anxiety and Depression ScaleBehavioural
Also called HADS
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire
Duke-UNC Functional Social Support QuestionnaireBehavioural
A 14-item, self-administered, multidimensional, functional social support questionnaire has been reduced to an 11 items to a brief and easy-to-complete two-scale, eight-item functional social support instrument.
Distress ThermometerBehavioural
Also called DT
The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress
FACT-BMTBehavioural
The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains
Psychosocial Assessments of Candidates for TransplantationBehavioural
Also called PACT
The PACT scale is a single page 10-item rating scale with high inter-rater reliability that has been used extensively in solid organ transplantation
| Study group | Role | What they receive |
|---|---|---|
| Participant Cohort 1 | Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age. Receives: Behavioral: Hospital Anxiety and Depression Scale; Behavioral: Duke-UNC Functional Social Support Questionnaire; Behavioral: Distress Thermometer; Behavioral: FACT-BMT; Behavioral: Psychosocial Assessments of Candidates for Transplantation | |
| Participant Cohort 2 | Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater Receives: Behavioral: Hospital Anxiety and Depression Scale; Behavioral: Duke-UNC Functional Social Support Questionnaire; Behavioral: Distress Thermometer; Behavioral: FACT-BMT; Behavioral: Psychosocial Assessments of Candidates for Transplantation | |
| Physician Group 1: Primary Myeloma Therapy | Physicians in this group refer for cellular therapy but do not perform the infusions. Receives: Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM | |
| Physician Group 2: CAR Enabled | These physicians can order and infuse CAR T cells but not stem cells. Receives: Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM | |
| Physician Group 3: HCT and CAR Enabled | These physicians can order and infuse stem cells and CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of referral
To prospectively estimate the rates of referral and utilization of salvage autologous hematopoietic cell transplantation (HCT) and B cell maturation antigen (BCMA) Targeted Chimeric Antigen Receptor (CAR) autologous T cell therapies among patients with RRMM.
Measured: Up to 76 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start3 Nov 2023
- Primary completion3 May 2029 (estimated)
- Study completion3 May 2029 (estimated)
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 Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Landau, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126341
- Sponsor's protocol ID
- 23-166
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Study to Identify Barriers to Cellular Therapies in Patients With Plasma Cell Disorders PROACT PCD
- ClinicalTrials.gov ID
- NCT06126341
- Acronym / sponsor ID
- 23-166
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, BCMA CAR T-cell therapy, HCT, Memorial Sloan Kettering Cancer Center, 23-166
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 3 May 2029 (estimated)
- Study completion
- 3 May 2029 (estimated)
- First posted
- 13 Nov 2023 (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.
This is an observational study that will include both participants with relapsed/refractory Multiple Myeloma and their doctors. The purpose of this study is to gather information about the use of hematopoietic cell transplantation/HCT and B-cell maturation antigen /BCMS targeted chimeric antigen receptor/CAR autologous T-cell therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Participant Cohort 1 | – | Behavioral: Hospital Anxiety and Depression Scale, Behavioral: Duke-UNC Functional Social Support Questionnaire, Behavioral: Distress Thermometer, Behavioral: FACT-BMT, Behavioral: Psychosocial Assessments of Candidates for TransplantationRelapse/refractory multiple myeloma/RRMM patients less than 70 years of age. |
| Participant Cohort 2 | – | Behavioral: Hospital Anxiety and Depression Scale, Behavioral: Duke-UNC Functional Social Support Questionnaire, Behavioral: Distress Thermometer, Behavioral: FACT-BMT, Behavioral: Psychosocial Assessments of Candidates for TransplantationRelapse/refractory multiple myeloma/RRMM patients 70 years of age or greater |
| Physician Group 1: Primary Myeloma Therapy | – | Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMMPhysicians in this group refer for cellular therapy but do not perform the infusions. |
| Physician Group 2: CAR Enabled | – | Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMMThese physicians can order and infuse CAR T cells but not stem cells. |
| Physician Group 3: HCT and CAR Enabled | – | –These physicians can order and infuse stem cells and CAR T cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential participants contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigator may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study.
Key inclusion criteria (12 listed)
- Patient
- Diagnosis of Multiple Myeloma after January 1, 2017.
- Karnofsky Performance Status > 70%
- ≥ 2 lines of prior therapy
- Anticipated to start new a line of therapy for RRMM within the next 12 months
Key exclusion criteria (3 listed)
- Patient
- Active CNS disease
- Patients who already have a definitive plan are to be excluded
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 |
|---|---|---|
| Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMMPhysician investigators will review a lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM that discusses current information in regards to available cellular therapies in RRMM and a proposed treatment algorithm. | Other | Physician Group 1: Primary Myeloma Therapy, Physician Group 2: CAR Enabled |
| Hospital Anxiety and Depression ScaleAlso: HADSDepression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire | Behavioural | Participant Cohort 1, Participant Cohort 2 |
| Duke-UNC Functional Social Support QuestionnaireA 14-item, self-administered, multidimensional, functional social support questionnaire has been reduced to an 11 items to a brief and easy-to-complete two-scale, eight-item functional social support instrument. | Behavioural | Participant Cohort 1, Participant Cohort 2 |
| Distress ThermometerAlso: DTThe Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress | Behavioural | Participant Cohort 1, Participant Cohort 2 |
| FACT-BMTThe FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains | Behavioural | Participant Cohort 1, Participant Cohort 2 |
| Psychosocial Assessments of Candidates for TransplantationAlso: PACTThe PACT scale is a single page 10-item rating scale with high inter-rater reliability that has been used extensively in solid organ transplantation | Behavioural | Participant Cohort 1, Participant Cohort 2 |
Primary outcome
Rates of referral
Time frame: Up to 76 months
To prospectively estimate the rates of referral and utilization of salvage autologous hematopoietic cell transplantation (HCT) and B cell maturation antigen (BCMA) Targeted Chimeric Antigen Receptor (CAR) autologous T cell therapies among patients with RRMM.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Heather Landau, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 8 sites 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 12 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Rates of referral (time frame: Up to 76 months). 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 19 Feb 2026.