Plasma Cell DyscrasiaNCT02671448
Pilot Trial of Homebound Stem Cell Transplantation
A study testing Home monitoring teleconsult visits, Patient Reported Outcomes (PRO) and Caregiver Reported Outcomes instruments in people with Plasma Cell Dyscrasia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
In this study, the investigators plan to see what happens when a person receives care in the home setting. They want to find out if caring for a patient who has been treated with an ASCT in the home setting is feasible. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Cell Dyscrasia
- What is being tested?
- Home monitoring teleconsult visits, Patient Reported Outcomes (PRO) and Caregiver Reported Outcomes instruments
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Plasma cell dyscrasia
- Treatment plan including Autologous HSCT
- 18-80 years of age
- Appropriate homebound setting as defined by one of the following:
- Lodging at the MSK Residence.
- Staying at home or a "home equivalent" in any one of the zip codes as outlined in the appendix. Home equivalent is defined as a residence which may or may not be the primary residence of the patient.
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- "Home equivalent" must pass the "Home Environment Screening Tool" for homebound stem cell transplantation (not required for other MSK recognized lodging facility).
- Adequate caregiver support as defined by:
- Single or multiple informal caregivers willing and able to provide 24 hour a day, seven day a week supervision of the transplant recipient in their home or "home-like" environment.
- Caregiver willing and able to fulfill the basic stem cell transplant caregiver education requirements as determined by caregiver and healthcare team, including social worker
- Have Wi-Fi connection
- Appropriate third party payer coverage for "Homebound Stem Cell Transplant Program"
- Both patient and caregiver willing to give and sign informed consent.
Who cannot join
- Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
- Uncontrolled arrhythmias
- Active or uncontrolled pulmonary disease
- Karnofsky Performance Scale (KPS) score <80
- Sorror Co-morbidity index ≥ 4 except in patients with history of resected cancers
- Creatinine clearance (calculated or measured) of < 50 cc/minute
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- Inability of patient or caregiver to speak or read English (we currently do not have the manpower to translate nor staff a multilingual homebound stem cell transplant program with adequate educational materials).
- Inadequate housing arrangements
- Inadequate caregiver arrangements
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
In this study, the investigators plan to see what happens when a person receives care in the home setting. They want to find out if caring for a patient who has been treated with an ASCT in the home setting is feasible. They want to find out what effects good and/or bad this will have on the patient's recovery and treatment after ASCT. Studies in other institutions have shown that providing care in the home setting after ASCT is safe, increases patient satisfaction, and can decrease the risk of infection. It is our hope that this new approach of providing care in the home setting will prove to be a feasible and safe option for patients at Memorial Sloan Kettering Cancer Center (MSK).
- Conditions
- Plasma Cell Dyscrasia
- Being tested
- Home monitoring teleconsult visits, Patient Reported Outcomes (PRO), Caregiver Reported Outcomes instruments
- Keywords
- Homebound, Homecare, 15-022
- Medical subject headings
- Paraproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home monitoring teleconsult visitsBehavioural
A tablet will be provided to both the patient and the caregiver during the homecare portion of the study. The tablet will remain at the home, to be used by the patient and the caregiver during daily homecare visits to complete instruments/surveys and video diary recording sessions.
Patient Reported Outcomes (PRO)Behavioural
Distress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument
Caregiver Reported Outcomes instrumentsBehavioural
Distress Thermometer, Caregiver Reaction Assessment (CRA) Instrument, The Caregiver Quality of Life Index-Cancer (CQOLC) Scale, Satisfaction Questionnaire, Video Diary Entries
| Study group | Role | What they receive |
|---|---|---|
| Homebound After Stem Cell Transplantation | Experimental | The primary research outputs and measurements are the instruments/surveys, assessments, and video diaries to be completed by the patients, their caregivers and the healthcare providers during the time of the home transplantation care. Protocol-specific interventions during homebound care will continue until patient has achieved neutrophil engraftment. Post engraftment, standard of care practice will resume. Once discharged from homebound care, the patient will complete routine post-HSCT follow-up visits in the clinic setting. Receives: Behavioral: Home monitoring teleconsult visits; Behavioral: Patient Reported Outcomes (PRO); Behavioral: Caregiver Reported Outcomes instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
readmission rate by 21 days post HSCT
the homebound procedure will be considered promising if no more than 10 patients are readmitted to the hospital within 21 days.
Measured: 21 days post HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell DyscrasiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot trial will be the first attempt at developing a homebound hematopoietic stem cell transplant (HSCT) program at MSK.
- Enrolment
- 83 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
- NCT02671448
- Sponsor's protocol ID
- 15-022
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2016
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Homebound Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02671448
- Acronym / sponsor ID
- 15-022
- Conditions
- Plasma Cell Dyscrasia
- Keywords
- Homebound, Homecare, 15-022
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- 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.
In this study, the investigators plan to see what happens when a person receives care in the home setting. They want to find out if caring for a patient who has been treated with an ASCT in the home setting is feasible. They want to find out what effects good and/or bad this will have on the patient's recovery and treatment after ASCT. Studies in other institutions have shown that providing care in the home setting after ASCT is safe, increases patient satisfaction, and can decrease the risk of infection. It is our hope that this new approach of providing care in the home setting will prove to be a feasible and safe option for patients at Memorial Sloan Kettering Cancer Center (MSK).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- This pilot trial will be the first attempt at developing a homebound hematopoietic stem cell transplant (HSCT) program at MSK.
| Arm | Type | Receives |
|---|---|---|
| Homebound After Stem Cell Transplantation | Experimental | Behavioral: Home monitoring teleconsult visits, Behavioral: Patient Reported Outcomes (PRO), Behavioral: Caregiver Reported Outcomes instrumentsThe primary research outputs and measurements are the instruments/surveys, assessments, and video diaries to be completed by the patients, their caregivers and the healthcare providers during the time of the home transplantation care. Protocol-specific interventions during homebound care will continue until patient has achieved neutrophil engraftment. Post engraftment, standard of care practice will resume. Once discharged from homebound care, the patient will complete routine post-HSCT follow-up visits in the clinic setting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of Plasma cell dyscrasia
- Treatment plan including Autologous HSCT
- 18-80 years of age
- Appropriate homebound setting as defined by one of the following:
- Adequate caregiver support as defined by:
Key exclusion criteria (9 listed)
- Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
- Uncontrolled arrhythmias
- Active or uncontrolled pulmonary disease
- Karnofsky Performance Scale (KPS) score <80
- Sorror Co-morbidity index ≥ 4 except in patients with history of resected cancers
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 |
|---|---|---|
| Home monitoring teleconsult visitsA tablet will be provided to both the patient and the caregiver during the homecare portion of the study. The tablet will remain at the home, to be used by the patient and the caregiver during daily homecare visits to complete instruments/surveys and video diary recording sessions. | Behavioural | Homebound After Stem Cell Transplantation |
| Patient Reported Outcomes (PRO)Distress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument | Behavioural | Homebound After Stem Cell Transplantation |
| Caregiver Reported Outcomes instrumentsDistress Thermometer, Caregiver Reaction Assessment (CRA) Instrument, The Caregiver Quality of Life Index-Cancer (CQOLC) Scale, Satisfaction Questionnaire, Video Diary Entries | Behavioural | Homebound After Stem Cell Transplantation |
Primary outcome
readmission rate by 21 days post HSCT
Time frame: 21 days post HSCT
the homebound procedure will be considered promising if no more than 10 patients are readmitted to the hospital within 21 days.
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 14 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home monitoring teleconsult visits, Patient Reported Outcomes (PRO) and Caregiver Reported Outcomes instruments in people with Plasma Cell Dyscrasia, run by Memorial Sloan Kettering Cancer Center 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 13 inclusion and 9 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 14 Jul 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?
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?
readmission rate by 21 days post HSCT (time frame: 21 days post HSCT). 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 14 Jul 2026.