Multiple MyelomaPhase 2NCT05288062
Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma
A Phase 2 study testing Bone Marrow Biopsy, Dexamethasone and Lenalidomide in people with Multiple Myeloma and Recurrent Multiple Myeloma, run by Mayo Clinic at 4 sites in United States.
Trial summary
This phase II trial studies the effect of immunomodulatory drug(s) in combination with a corticosteroid drug in treating patients with multiple myeloma or smoldering multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Bone Marrow Biopsy, Dexamethasone and Lenalidomide
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jun 2022to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >= 18 years
- COHORT A: Patient must have untreated smoldering multiple myeloma which is defined by the presence of 10% or more but less than 60% clonal plasma cells in the bone marrow and the absence of any of the following myeloma related symptoms or laboratory and radiographic abnormalities: anemia, hypercalcemia, renal insufficiency, hypercalcemia, serum free light chain ratio of greater than 100 or more than one focal marrow multiple myeloma lesion on magnetic resonance imaging (MRI)
- COHORT B: Patient must have newly diagnosed myeloma requiring treatment and no prior therapies
- COHORT C: Patient must have relapsed or refractory multiple myeloma with at least one prior therapy for their multiple myeloma but not refractory to all Immunomodulatory drugs (IMiDs)
- COHORT D: Patient must have relapsed or refractory multiple myeloma with lenalidomide as part of a maintenance regimen as their most recent therapy
- Measurable disease
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- Provide written informed consent
- Patient must be considered for treatment with an Immunomodulatory drug (IMiD) containing regimen
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
- Hemoglobin >= 7.0 g/dL (obtained =< 14 days prior to registration)
- Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to registration)
- Platelet count >= 50,000/mm^3 (obtained =< 14 days prior to registration)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =< 1.5 X ULN (obtained =< 14 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) <=3 x ULN (=< 5 x ULN for patients with liver involvement) (obtained =< 14 days prior to registration)
- Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =< 14 days prior to registration)
- Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
- Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- Willingness to provide mandatory blood and bone marrow specimens for correlative research
- Willing to follow the requirements of the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) program
Who cannot join
- An agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- History of myocardial infarction =< 6 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Evaluating Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma
This phase II trial studies the effect of immunomodulatory drug(s) in combination with a corticosteroid drug in treating patients with multiple myeloma or smoldering multiple myeloma. Immunomodulatory drugs such as lenalidomide and pomalidomide work through a variety of mechanisms to affect the function of the immune system. They are widely used as treatment for multiple myeloma and remain the backbone of therapy for both newly diagnosed patients and patients that have multiple myeloma that has come back after treatment (relapsed). Corticosteroid drugs like dexamethasone are strong anti-inflammatory agents that are also widely used to treat patients with multiple myeloma. This study may help doctors find out how patients respond to one treatment cycle of immunomodulatory drug(s) in combination with dexamethasone. This may help doctors determine which combinations of drugs work best in treating patients with multiple myeloma or smoldering multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine response rates (>= partial response [PR]) of prospectively treated multiple myeloma (MM) patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
SECONDARY OBJECTIVE:
- To compare response rates of MM among African-Americans (AA) and white patients to a combination of an immunomodulator and dexamethasone.
II. To establish correlation of biomarkers in treated MM patients with the combination of an immunomodulator and dexamethasone to the depth of hematological response observed in new or previously treated patients.
CORRELATIVE OBJECTIVE:
- To identify biomarkers that predict response rates of untreated smoldering MM and MM patients to a combination of an immunomodulator and dexamethasone.
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT A: Patients with smoldering multiple myeloma receive lenalidomide orally (PO) once daily (QD) alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
COHORT B: Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
COHORT C: Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
COHORT D: Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
After completion of study treatment, patients are followed up within 7 days.
- Conditions
- Multiple Myeloma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma, Smoldering Multiple Myeloma
- Being tested
- Bone Marrow Biopsy, Dexamethasone, Lenalidomide, Pomalidomide
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow aspirate/biopsy
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given orally
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given orally
PomalidomideDrug
Also called 4-Aminothalidomide, Actimid, CC-4047, Imnovid
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (lenalidomide, dexamethasone) | Experimental | Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Bone Marrow Biopsy; Drug: Dexamethasone; Drug: Lenalidomide |
| Cohort B (lenalidomide, dexamethasone) | Experimental | Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Receives: Procedure: Bone Marrow Biopsy; Drug: Dexamethasone; Drug: Lenalidomide |
| Cohort C (lenalidomide, dexamethasone, pomalidomide) | Experimental | Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Bone Marrow Biopsy; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pomalidomide |
| Cohort D (lenalidomide, dexamethasone, pomalidomide) | Experimental | Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C. Receives: Procedure: Bone Marrow Biopsy; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rates (RR) at First Assessment
RR is defined as a binary variable. A success will be defined as patient who achieve a response of a partial response (PR) or better using the International Myeloma Working Group (IMWG) criteria. Biomarkers of interest will be identified and categorized into clinically relevant groups (e.g. positive vs. negative) by evaluating baseline and post treatment (after cycle one) biospecimens. RR will be estimated within each biomarker. Each cohort (A-D) will be evaluated separately and independently.
Measured: 21 days
Secondary outcomes (2)
Response Rates (RR) Among African American (AA) and White Patients
Pearson's Chi-square (or Fischer Exact) test and 95% confidence intervals will be estimated to compare patients of different races descriptively.
Measured: Up to completion of 1 cycle of treatment (21 days)
Depth of Hematological Responses
Correlation between the depth of hematological responses and biomarkers will be estimated. Logistic regressions and chi square (or Fischer exact) testing will be utilized.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Jun 2022
- Primary completion25 Feb 2024
- Study completion30 Jul 2025
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson I. Gonsalves, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288062
- Sponsor's protocol ID
- MC210809
- Other IDs
- 21-006597
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2022
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05288062
- Acronym / sponsor ID
- MC210809
- Conditions
- Multiple Myeloma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma, Smoldering Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the effect of immunomodulatory drug(s) in combination with a corticosteroid drug in treating patients with multiple myeloma or smoldering multiple myeloma. Immunomodulatory drugs such as lenalidomide and pomalidomide work through a variety of mechanisms to affect the function of the immune system. They are widely used as treatment for multiple myeloma and remain the backbone of therapy for both newly diagnosed patients and patients that have multiple myeloma that has come back after treatment (relapsed). Corticosteroid drugs like dexamethasone are strong anti-inflammatory agents that are also widely used to treat patients with multiple myeloma. This study may help doctors find out how patients respond to one treatment cycle of immunomodulatory drug(s) in combination with dexamethasone. This may help doctors determine which combinations of drugs work best in treating patients with multiple myeloma or smoldering multiple myeloma.
Detailed description
PRIMARY OBJECTIVE:
- To determine response rates (>= partial response [PR]) of prospectively treated multiple myeloma (MM) patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
SECONDARY OBJECTIVE:
- To compare response rates of MM among African-Americans (AA) and white patients to a combination of an immunomodulator and dexamethasone.
II. To establish correlation of biomarkers in treated MM patients with the combination of an immunomodulator and dexamethasone to the depth of hematological response observed in new or previously treated patients.
CORRELATIVE OBJECTIVE:
- To identify biomarkers that predict response rates of untreated smoldering MM and MM patients to a combination of an immunomodulator and dexamethasone.
OUTLINE: Patients are assigned to 1 of 4 cohorts.
COHORT A: Patients with smoldering multiple myeloma receive lenalidomide orally (PO) once daily (QD) alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
COHORT B: Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
COHORT C: Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
COHORT D: Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
After completion of study treatment, patients are followed up within 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A (lenalidomide, dexamethasone) | Experimental | Procedure: Bone Marrow Biopsy, Drug: Dexamethasone, Drug: LenalidomidePatients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. |
| Cohort B (lenalidomide, dexamethasone) | Experimental | Procedure: Bone Marrow Biopsy, Drug: Dexamethasone, Drug: LenalidomidePatients with newly diagnosed multiple myeloma receive treatment as in Cohort A. |
| Cohort C (lenalidomide, dexamethasone, pomalidomide) | Experimental | Procedure: Bone Marrow Biopsy, Drug: Dexamethasone, Drug: Lenalidomide, Drug: PomalidomidePatients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. |
| Cohort D (lenalidomide, dexamethasone, pomalidomide) | Experimental | Procedure: Bone Marrow Biopsy, Drug: Dexamethasone, Drug: Lenalidomide, Drug: PomalidomidePatients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age >= 18 years
- COHORT A: Patient must have untreated smoldering multiple myeloma which is defined by the presence of 10% or more but less than 60% clonal plasma cells in the bone marrow and the absence of any of the following myeloma related symptoms or laboratory and radiographic abnormalities: anemia, hypercalcemia, renal insufficiency, hypercalcemia, serum free light chain ratio of greater than 100 or more than one focal marrow multiple myeloma lesion on magnetic resonance imaging (MRI)
- COHORT B: Patient must have newly diagnosed myeloma requiring treatment and no prior therapies
- COHORT C: Patient must have relapsed or refractory multiple myeloma with at least one prior therapy for their multiple myeloma but not refractory to all Immunomodulatory drugs (IMiDs)
- COHORT D: Patient must have relapsed or refractory multiple myeloma with lenalidomide as part of a maintenance regimen as their most recent therapy
Key exclusion criteria (9 listed)
- An agent that has known genotoxic, mutagenic and teratogenic effects:
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
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 |
|---|---|---|
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow aspirate/biopsy | Procedure or surgery | Cohort A (lenalidomide, dexamethasone), Cohort B (lenalidomide, dexamethasone), Cohort C (lenalidomide, dexamethasone, pomalidomide), Cohort D (lenalidomide, dexamethasone, pomalidomide) |
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven orally | Drug | Cohort A (lenalidomide, dexamethasone), Cohort B (lenalidomide, dexamethasone), Cohort C (lenalidomide, dexamethasone, pomalidomide), Cohort D (lenalidomide, dexamethasone, pomalidomide) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven orally | Drug | Cohort A (lenalidomide, dexamethasone), Cohort B (lenalidomide, dexamethasone), Cohort C (lenalidomide, dexamethasone, pomalidomide), Cohort D (lenalidomide, dexamethasone, pomalidomide) |
| PomalidomideAlso: 4-Aminothalidomide, Actimid, CC-4047, ImnovidGiven orally | Drug | Cohort C (lenalidomide, dexamethasone, pomalidomide), Cohort D (lenalidomide, dexamethasone, pomalidomide) |
Primary outcome
Response Rates (RR) at First Assessment
Time frame: 21 days
RR is defined as a binary variable. A success will be defined as patient who achieve a response of a partial response (PR) or better using the International Myeloma Working Group (IMWG) criteria. Biomarkers of interest will be identified and categorized into clinically relevant groups (e.g. positive vs. negative) by evaluating baseline and post treatment (after cycle one) biospecimens. RR will be estimated within each biomarker. Each cohort (A-D) will be evaluated separately and independently.
2 secondary outcomes
Response Rates (RR) Among African American (AA) and White Patients
Time frame: Up to completion of 1 cycle of treatment (21 days)
Depth of Hematological Responses
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink 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.
Wilson I. Gonsalves, M.D. principal investigator
Mayo Clinic in Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone Marrow Biopsy, Dexamethasone and Lenalidomide in people with Multiple Myeloma and Recurrent Multiple Myeloma, run by Mayo Clinic at 4 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 21 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: stopped early, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rates (RR) at First Assessment (time frame: 21 days). 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 28 Sep 2026.