Multiple MyelomaPhase 2NCT06997081
ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (ADVANCE 2.0)
A Phase 2 study testing Lenalidomide, Dexamethasone and Elranatamab in people with Multiple Myeloma, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma. 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?
- Lenalidomide, Dexamethasone and Elranatamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 30 Sep 2030
- Phase
- Phase 2
- 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
Who may be able to join
- Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the IMWG diagnostic criteria and measurable disease within the past 4 weeks (or past 8 weeks if patient received pre-study MM therapy) based on one of the following:
- Serum monoclonal protein ≥ 1.0 g/dL
- Urine monoclonal protein ≥ 200 mg/24 hour
- Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal kappa/lambda ratio
- Note:
- Patients who have evaluable disease based on samples other than urine do not need to have urine evaluated for initial or subsequent response assessments.
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- Because the primary endpoint is MRD negativity rate, per the discretion of the Principal Investigator (PI), patients without measurable disease (e.g., M-spike <1.0 g/dL) may also be enrolled in line with the International Myeloma Working Group (IMWG) MM response criteria.
- Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following (Note: Myeloma defining event does not need to be based on repeat testing done at screening if previous pathology, radiology, etc., confirm diagnosis of myeloma per IMWG):
- Hypercalcemia: serum calcium >0.25 mmol/L (>1.0 mg/dL) above upper limit of normal (ULN) or ≥2.75 mmol/L (11 mg/dL)
- Anemia: hemoglobin value <10 g/dL or >2 g/dL below lower limit of normal (LLN)
- Bone disease: ≥1 lytic lesions on skeletal X-ray, computed tomography (CT), or positron emission tomography (PET)-CT. For patients with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells
- Clonal bone marrow plasma cell percentage ≥60%
- Involved/un-involved serum free light chain ratio ≥100 and involved free light chain ≥100 mg/L.
- >1 focal lesion on magnetic resonance imaging study (lesion must be >5 mm) in size
- For patients with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells
- Patients must have measurable disease within the past 4 weeks, which is defined by any one of the following:
- Serum monoclonal protein ≥ 0.5 g/dL Urine monoclonal protein >200 mg/24 hour
- Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal kappa/lambda serum free light chain ratio (reference: 0.26-1.65)
- Other measurable disease as defined by the IMWG
- Because the primary endpoint is MRD negativity based on bone marrow analysis, a patient without measurable disease in blood or urine may be enrolled and assessed for MRD negativity.
- Note:
- Participants who have evaluable disease based on samples other than urine do not need to have urine evaluated for subsequent responses.
- In participants who received minimal prior therapy within the allowable range per exclusion criteria 1, patients should have had documented measurable disease within 4 weeks of starting that respective therapy if currently unmeasurable.
- Adult male and female participants ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Refer to Appendix A)
- Participants must have adequate organ and marrow function ≤45 days as defined below:
- Absolute neutrophil count (ANC) >1.0 K cells/μL; At the discretion of the Investigator, patients with an ANC of 0.5 K/μL-1.0 K/μL may also be enrolled if clinically appropriate (eg, patients with a baseline neutropenia that is chronic and/or ethnic neutropenia and that does not cause complications, e.g, no history of chronic infections).
- Platelet count >75 K cells/μL
- Hemoglobin >8 g/dL (transfusions are permissible if the cause of the anemia is other than myeloma)
- Total bilirubin <1.5 X upper limit of normal (ULN).
- Note: Isolated total bilirubin ≥1.5 X ULN with conjugated [direct] bilirubin <1.5 X ULN is allowed for those participants with known Gilbert's syndrome.
- Aspartate aminotransferase (AST)/ alanine transaminase (ALT) ≤2.5 X ULN
- GFR ≥30 mL/min based on Modification of Diet in Renal Disease (MDRD) 4-variable Formula calculation (Appendix 17.2) or creatine clearance (CrCl) measured by a 24-hour urine collection. (The estimated glomerular filtration rate (eGFR) may also be determined by using other widely accepted methods as clinically indicated, ie, Cockcroft-Gault method or the chronic kidney disease (CKD)-epidemiology collaboration (EPI) per institutional standards.
- Participants must be willing, able, and agree to enrolling in the lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.
- A female participant of childbearing potential must have a negative serum or urine pregnancy test at screening (at or within 45 days of study enrollment) and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
- A female participant must be:
- Not of childbearing potential, or
- Of childbearing potential and practicing at least 1 highly effective method of contraception as described in Section 5.7
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 4 weeks after the last dose of lenalidomide or 4 months after the last dose of elranatamab. Female participants should consider preservation of eggs prior to study treatment, as anti-cancer treatments may impair fertility.
- A female participant must agree to not breastfeed during the study and for a period of at least 4 weeks after the last dose of lenalidomide or 4 months after the last dose of elranatamab.
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for a period of at least 4 weeks after receiving the last dose of study treatment. If the male participant's partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide), and the female partner of the male participant must also be practicing a highly effective method of contraception. Refer to Section 5.7 for contraception requirements.
- Note: If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for period of 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment, as anti-cancer treatments may impair fertility.
- Ability of the patient to understand and the willingness to sign a written informed consent document.
- Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
Who cannot join
- Participants receiving >1 cycle of prior treatment or concurrent systemic treatment for MM with the following exceptions:
- Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted
- Bone targeting agents are permitted
- Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted
- Prior MM treatments, such as immunomodulatory drugs (IMIDs) or non-MM drugs in clinical trials for smoldering myeloma is permitted with a washout period of 2 weeks from last dose. Patients with Smoldering Multiple Myeloma (SMM) previously treated with carfilzomib are excluded.
- Patients with measurable disease who received up to one cycle of any therapy within 60 days with a washout period of 2 weeks from last dose (on a trial or outside a trial) are eligible (Note: Measurable disease is defined as one or more of the following: Serum monoclonal protein ≥ 1.0 g/dL, Urine monoclonal protein ≥ 200 mg/24 hour and/or involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal kappa/lambda ratio.)
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- Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
- Major surgery within 14 days prior to enrollment
- Peripheral neuropathy (PN)/history of PN ≥ 3
- Patients who are receiving any other anti-myeloma investigational agents.
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior or during to therapy.
- Patient has any of the following:
- Human immunodeficiency virus (HIV)-positive with 1 or more of the following:
- History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation 4 (CD4) count <350 cells/mm3
- Detectable viral load during screening or within 6 months prior to screening
- Not receiving highly active anti-retroviral therapy
- Had a change in antiretroviral therapy within 6 months of the start of screening
- Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the Medical Monitor
- Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)-DNA positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and/or antibodies to hepatitis B surface antigen (anti-HBs)) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status Exception: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR
- Active hepatitis C infection as measured by positive Hepatitis C Virus (HCV)-ribonucleic acid (RNA) testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for participants with known or suspected of having COPD or asthma, and participants must be excluded if FEV1 <50% of predicted normal.
- Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that FEV1 testing is required for participants with known or suspected asthma, and participants must be excluded if FEV1 <50% of predicted normal.
- Severe acute respiratory syndrome (SARS) coronavirus (COV) 2 (SARS-CoV-2) PCR testing is mandated within 5 days prior to enrollment. Exclusion if positive or suspected infection. Also, negative chest imaging needs to be confirmed prior to enrollment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study.
- Female patient refuses to discontinue breastfeeding her infant during study treatment or within 3 months after receiving the last dose of study treatment.
- Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft ≤6 months prior to study enrollment
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities
- Unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina)
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection, venous thromboembolic disease, hemorrhage, pulmonary fibrosis, pneumonitis, active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing, or psychiatric illness/social situations within 2 weeks that would limit compliance with study requirements.
- Active malignancy other than SMM requiring treatment in the past 3 years. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
- Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements. Participants with active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, SARS-CoV-2, and known HIV or AIDS-related illness. Comments regarding specific circumstances follow. Active infection must be resolved at least 21 days prior to enrollment. Patients treated with systemic anti-infective agents within 28 days prior to enrollment are not eligible. Prophylactic use of systemic agents is permitted.
- Patients with impaired decision-making capacity will not be enrolled on this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Carl Landgren, MD, 3052436578 ext. 243, col15@miami.edu
Dickran Kazandijan, MD, 3052435001, dkazandjian@miami.edu
About this study
Official title: Elranatamab, Lenalidomide, Dexamethasone in Newly Diagnosed Multiple Myeloma, a Clinical and Correlative Phase 2 Study
The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Dexamethasone, Elranatamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Participants will receive 25mg of Lenalidomide orally on Days 2-21 of Cycle 1, then 25 mg by mouth on Days 1-21 of the remaining cycles.
DexamethasoneDrug
Participants will receive 20mg of Dexamethasone orally on Days 1, 3, 8, and 15 of Cycle 1, then 4mg orally on Days 1 and 15 of Cycles 4-6.
ElranatamabDrug
Participants will receive 12mg Elranatamab subcutaneous (SC) on Cycle 1; 32mg subcutaneous (SC) on Cycle 1 Day 3; 76mg subcutaneous (SC) on Cycle 1 Day 8 and Day 15. Then, participants will receive 76mg subcutaneous (SC) on Days 1 and 15 of Cycles 2-6. Lastly, participants will receive Elranatamab subcutaneous (SC) on Day 1 of the remaining cycles.
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab in combination with lenalidomide and dexamethasone (ERd) | Experimental | Participants in this group will receive standard of care (SOC) therapy with ERd combination treatment.
Total participation duration is up to 2.5 years. Receives: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Elranatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) (10^-5 sensitivity)
Minimal residual disease (MRD) is defined as 0 residual clonal cells in a bone marrow biopsy sample MRD negativity (10^-5 sensitivity) after 12 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment.
Measured: Up to 2 years
Secondary outcomes (6)
Best Overall Response
The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Will be measured during the first 12 and 24 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment.
Will be measured in months.
Measured: Up to 24 months
Sustained MRD Negativity
The sustained rate of MRD-negativity among participants will be reported. The duration of time in months measured from the first time the participant achieves an MRD-negative bone marrow (BM) biopsy result until the time the participant has relapsed from MRD-negativity objectively documented with an MRD-positive BM result.
Measured: Up to 2 years
Minimal residual disease (MRD) (10^-6 sensitivity)
Minimal residual disease (MRD) negativity ( 10^-6 sensitivity) is defined as 0 residual clonal cells in a bone marrow biopsy anytime in the first 24 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment.
Measured: Up to 2 years
Progression-Free Survival (PFS)
Progression-free survival (PFS) among study participants will be assessed during treatment and clinical follow-up. PFS is defined as the time in months from start of treatment until disease progression or death.
Measured: Up to 24 months
Overall Survival
Overall survival (OS) among study participants will be assessed during treatment and clinical follow-up. OS is defined as the time in months from start of treatment until death from any cause.
Measured: Up to 24 months
Incidence of Cytokine Release Syndrome (CRS)
Incidence of cytokine release syndrome (CRS), grade of CRS, and management of potentially recurring CRS. CRS will be evaluated according to the standards released by American Society for Transplantation and Cellular Therapy (ASTCT) criteria in 2019.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start16 Sep 2025
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (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 University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Carl Ola Landgren, MD, PhD, University of Miami
- Investigators
- Carl O Landgren, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997081
- Sponsor's protocol ID
- 20250076
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elranatamab, Lenalidomide, Dexamethasone in Newly Diagnosed Multiple Myeloma, a Clinical and Correlative Phase 2 Study
- ClinicalTrials.gov ID
- NCT06997081
- Acronym / sponsor ID
- 20250076
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 30 May 2025 (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 this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elranatamab in combination with lenalidomide and dexamethasone (ERd) | Experimental | Drug: Lenalidomide, Drug: Dexamethasone, Drug: ElranatamabParticipants in this group will receive standard of care (SOC) therapy with ERd combination treatment. Total participation duration is up to 2.5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (46 listed)
- Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the IMWG diagnostic criteria and measurable disease within the past 4 weeks (or past 8 weeks if patient received pre-study MM therapy) based on one of the following:
- Evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following (Note: Myeloma defining event does not need to be based on repeat testing done at screening if previous pathology, radiology, etc., confirm diagnosis of myeloma per IMWG):
- Patients must have measurable disease within the past 4 weeks, which is defined by any one of the following:
- Adult male and female participants ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Refer to Appendix A)
Key exclusion criteria (37 listed)
- Participants receiving >1 cycle of prior treatment or concurrent systemic treatment for MM with the following exceptions:
- Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
- Major surgery within 14 days prior to enrollment
- Peripheral neuropathy (PN)/history of PN ≥ 3
- Patients who are receiving any other anti-myeloma investigational agents.
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 |
|---|---|---|
| LenalidomideParticipants will receive 25mg of Lenalidomide orally on Days 2-21 of Cycle 1, then 25 mg by mouth on Days 1-21 of the remaining cycles. | Drug | Elranatamab in combination with lenalidomide and dexamethasone (ERd) |
| DexamethasoneParticipants will receive 20mg of Dexamethasone orally on Days 1, 3, 8, and 15 of Cycle 1, then 4mg orally on Days 1 and 15 of Cycles 4-6. | Drug | Elranatamab in combination with lenalidomide and dexamethasone (ERd) |
| ElranatamabParticipants will receive 12mg Elranatamab subcutaneous (SC) on Cycle 1; 32mg subcutaneous (SC) on Cycle 1 Day 3; 76mg subcutaneous (SC) on Cycle 1 Day 8 and Day 15. Then, participants will receive 76mg subcutaneous (SC) on Days 1 and 15 of Cycles 2-6. Lastly, participants will receive Elranatamab subcutaneous (SC) on Day 1 of the remaining cycles. | Drug | Elranatamab in combination with lenalidomide and dexamethasone (ERd) |
Primary outcome
Minimal residual disease (MRD) (10^-5 sensitivity)
Time frame: Up to 2 years
Minimal residual disease (MRD) is defined as 0 residual clonal cells in a bone marrow biopsy sample MRD negativity (10^-5 sensitivity) after 12 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment.
6 secondary outcomes
Best Overall Response
Time frame: Up to 24 months
Sustained MRD Negativity
Time frame: Up to 2 years
Minimal residual disease (MRD) (10^-6 sensitivity)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival
Time frame: Up to 24 months
Incidence of Cytokine Release Syndrome (CRS)
Time frame: Up to 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 21 Sep 2026.
- Individual participant dataSharing planned: No
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Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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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.
Carl O Landgren, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, Dexamethasone and Elranatamab in people with Multiple Myeloma, run by University of Miami 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 46 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 21 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 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.
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?
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?
Contact Carl O Landgren, MD ((305) 243-6578, col15@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease (MRD) (10^-5 sensitivity) (time frame: Up to 2 years). 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 21 Sep 2026.