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Compares treatment options for Multiple Myeloma, Newly Diagnosed
Official title Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
ClinicalTrials.gov ID: NCT06974786
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma, newly diagnosed.
Also referred to as Elrexfio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Age \>18 years with no upper age limit.
- Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for...
- Eligible for ASCT according to institutional policy as evaluated by investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).
- Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).
You likely can't join if
- Diagnosis of primary light chain amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia, or central nervous system (CNS)...
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the elranatamab...
- Prior or concurrent exposure to any of the following: c. Any anti-BCMA therapy. d. Epigenetic therapy, or treatment with an investigational drug or...
- Minimum washout period for prior therapy:
- PI therapy - 14 days.
- IMiD agent therapy -14 days.
See the full eligibility criteria
Who can join
- Age \>18 years with no upper age limit.
- Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
- Eligible for ASCT according to institutional policy as evaluated by investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).
- Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).
- Measurable disease meeting at least 1 of the following criteria (at the time of diagnosis): a. Serum monoclonal (M) protein ≥1.0 g/dl (≥0.5 g/dl if IgA, IgD, IgE or IgM MM). b. ≥200 mg of M protein/24h in the urine. c...
- Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identified from a high disease burden sample obtained as SoC and enabling MRD testing during screening phase.
- Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment:
- Hemoglobin ≥8g/dL without prior red blood cells (RBC) transfusion within 14 days before the laboratory test; recombinant human erythropoietin use is permitted
- Platelets ≥75,000/µl
- Absolute neutrophil count ≥1,000/µl (prior growth factor support is permitted but must be without support for 7 days for granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating Factor...
- Aspartate aminotransferase and alanine aminotransferase ≤2.5 × upper limit of normal (ULN)
- Renal function: Creatinine clearance (CrCl) ≥40 mL/min based on calculation using Cockcroft-Gault formula or measured by a 24-hour urine collection.
- Total bilirubin ≤2 × ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤3 × ULN is required)
- Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
- Achievement of at least PR to induction therapy, without prior progression of disease.
- Prior completion of standard of care mobilization and collection of stem cells (minimum 2 × 106 CD34+ cells/kg) without use of chemotherapy mobilization, any time prior to or during screening phase.
- A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy...
- A woman must be: a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent...
- A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.
- A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days...
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
- Must sign an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to...
- All participants must agree to comply with and be enrolled in Revlimid Risk Evaluation and Mitigation Strategy (REMS) program.
- All participants must agree to comply with and be enrolled in elranatamab Risk Evaluation and Mitigation Strategy (REMS) program.
- All participants must meet institution-specific criteria for ASCT eligibility as assessed by the Investigator.
What rules you out
- Diagnosis of primary light chain amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia, or central nervous system (CNS) involvement by MM.
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the elranatamab Investigator's Brochure [IB] and appropriate package inserts).
- Prior or concurrent exposure to any of the following: c. Any anti-BCMA therapy. d. Epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5...
- Minimum washout period for prior therapy:
- PI therapy - 14 days.
- IMiD agent therapy -14 days.
- Anti CD38 monoclonal therapy - 14 days.
- Corticosteroids - 7 days.
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging and lumbar cytology are required.
- Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are: a. Non-muscle invasive bladder cancer treated...
- History of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS)-related illness.
- Active or recent infection (including SARS-COV-2). Participants with prior or recent infection must have infection resolved for \>21 days and no use of systemic anti-infective therapy for \>28 days.
- Hepatitis B infection (i.e., hepatitis B surface antigen [HBsAg] or hepatitis B virus [HBV]-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection...
- Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic...
- Uncontrolled diabetes.
- Acute diffuse infiltrative pulmonary disease.
- 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.
- Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status.
- Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the...
- History of non-compliance with recommended medical treatments.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Denver, Colorado, United States
- Iowa City, Iowa, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Norfolk, Virginia, United States
- Madison, Wisconsin, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Denver, Colorado, United States; Iowa City, Iowa, United States; Chapel Hill, North Carolina, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.