Multiple MyelomaNCT05271630
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
An observational study of Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT). 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?
- Autologous Stem Cell Transplant, Immunomodulatory Agent and Proteasome Inhibitor
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Myeloma patients receiving treatment at Moffitt Cancer Center
Who may be able to join
- All MM patients (18 years or greater) receiving autologous transplantation given as first line therapy (Melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate.
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Histologically confirmed diagnosis of multiple myeloma.
- Received high dose melphalan (≥ 140 mg/m2) followed by ASCT based on the institutional guidelines and within +60 and +180 after ASCT at the time of maintenance initiation.
- Disease status must be very good partial response (VGPR), complete remission (CR), or stringent complete remission (sCR) per IMWG response criteria at time of study entry.
- Measurable disease at diagnosis per IMWG criteria serum M spike ≥ 1g/dL, or Urine M protein ≥ 200 mg/24h or involved free light chain ≥ 100 mg/L with an abnormal ratio.
- Patients must have the Clonoseq ID sample showing a trackable clone in bone marrow.
Who cannot join
- Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
- Prior evidence of disease progression
- Patients who have other malignancy associated with a high risk of progression in the next 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).
Read the detailed description
This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.
- Conditions
- Multiple Myeloma
- Being tested
- Autologous Stem Cell Transplant, Immunomodulatory Agent, Proteasome Inhibitor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Stem Cell TransplantOther
This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT
Immunomodulatory AgentDrug
ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant
Proteasome InhibitorDrug
ASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant
| Study group | Role | What they receive |
|---|---|---|
| Single Maintenance After Autologous Stem Cell Transplant | Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma Receives: Other: Autologous Stem Cell Transplant; Drug: Immunomodulatory Agent | |
| Double Maintenance After Autologous Stem Cell Transplant | Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma. Receives: Other: Autologous Stem Cell Transplant; Drug: Immunomodulatory Agent; Drug: Proteasome Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD conversion rate
To determine rate of MRD conversion (positive to negative) in MM patients receiving an immunomodulatory drug in combination with a proteasome inhibitor as maintenance therapy 1-year post transplant.
Measured: At 1 year after transplant
Secondary outcomes (3)
Progression Free Survival (PFS) at 1 Year
PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval
Measured: At 1 Years
Progression Free Survival (PFS) at 2 Years
PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval
Measured: At 2 years
MRD by NGS Clonoseq testing
MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start20 Apr 2022
- Primary completion4 Dec 2025
- Study completionDec 2026 (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 H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Adaptive Biotechnologies
- Responsible party
- Sponsor
- Investigators
- Doris Hansen, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271630
- Sponsor's protocol ID
- MCC-20816
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2022
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05271630
- Acronym / sponsor ID
- MCC-20816
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Adaptive Biotechnologies
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Mar 2022 (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.
The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).
Detailed description
This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Maintenance After Autologous Stem Cell Transplant | – | Other: Autologous Stem Cell Transplant, Drug: Immunomodulatory AgentProspectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma |
| Double Maintenance After Autologous Stem Cell Transplant | – | Other: Autologous Stem Cell Transplant, Drug: Immunomodulatory Agent, Drug: Proteasome InhibitorProspectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Myeloma patients receiving treatment at Moffitt Cancer Center
Key inclusion criteria (7 listed)
- All MM patients (18 years or greater) receiving autologous transplantation given as first line therapy (Melphalan at least 140 mg/m2) will be screened and enrolled in the study if they qualify and willing to participate.
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
- Histologically confirmed diagnosis of multiple myeloma.
- Received high dose melphalan (≥ 140 mg/m2) followed by ASCT based on the institutional guidelines and within +60 and +180 after ASCT at the time of maintenance initiation.
- Disease status must be very good partial response (VGPR), complete remission (CR), or stringent complete remission (sCR) per IMWG response criteria at time of study entry.
Key exclusion criteria (3 listed)
- Patients who have purely non-secretory multiple myeloma (i.e., the absence of a measurable protein in serum by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of electrophoresis and immunofixation)
- Prior evidence of disease progression
- Patients who have other malignancy associated with a high risk of progression in the next 2 years.
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 |
|---|---|---|
| Autologous Stem Cell TransplantThis observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT | Other | Double Maintenance After Autologous Stem Cell Transplant, Single Maintenance After Autologous Stem Cell Transplant |
| Immunomodulatory AgentASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant | Drug | Double Maintenance After Autologous Stem Cell Transplant, Single Maintenance After Autologous Stem Cell Transplant |
| Proteasome InhibitorASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant | Drug | Double Maintenance After Autologous Stem Cell Transplant |
Primary outcome
MRD conversion rate
Time frame: At 1 year after transplant
To determine rate of MRD conversion (positive to negative) in MM patients receiving an immunomodulatory drug in combination with a proteasome inhibitor as maintenance therapy 1-year post transplant.
3 secondary outcomes
Progression Free Survival (PFS) at 1 Year
Time frame: At 1 Years
Progression Free Survival (PFS) at 2 Years
Time frame: At 2 years
MRD by NGS Clonoseq testing
Time frame: At 2 years
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 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Doris Hansen, MD principal investigator
Moffitt Cancer Center
1 site 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 H. Lee Moffitt Cancer Center and Research Institute 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 7 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 2 Mar 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?
MRD conversion rate (time frame: At 1 year after transplant). 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 2 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.