ERd Combination Treatment in Newly Diagnosed Multiple Myeloma

NCT06997081 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20250076
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 years

Secondary Outcomes (6)

• Best Overall Response

  Up to 24 months

• Sustained MRD Negativity

  Up to 2 years

• Minimal residual disease (MRD) (10^-6 sensitivity)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 24 months

• Overall Survival

  Up to 24 months

Study Arms (1)

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.

Drug: Lenalidomide; Drug: Dexamethasone; Drug: Elranatamab

Interventions

Lenalidomide DRUG

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.

Elranatamab in combination with lenalidomide and dexamethasone (ERd)

Dexamethasone DRUG

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.

Elranatamab in combination with lenalidomide and dexamethasone (ERd)

Elranatamab DRUG

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.

Elranatamab in combination with lenalidomide and dexamethasone (ERd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Pfizer: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Carl O Landgren, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl O Landgren, MD

CONTACT

(305) 243-6578; col15@miami.edu

Dickran Kazandjian, MD

CONTACT

(305)243-5001; dkazandjian@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)