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Compares treatment options for Multiple Myeloma
Official title A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
ClinicalTrials.gov ID: NCT05623020
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
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
- Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);
- Urinary M-protein excretion ≥200 mg/24 hours;
- Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\ 1.65).
You likely can't join if
- Smoldering Multiple Myeloma.
- Monoclonal gammopathy of undetermined significance.
- Waldenströms Macroglobulinemia
- Plasma cell leukemia.
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or...
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in...
See the full eligibility criteria
- Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);
- Urinary M-protein excretion ≥200 mg/24 hours;
- Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\ 1.65).
- Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with...
- Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:
- Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
- Participants with important comorbidities likely to have a negative impact on side effects of high dose chemotherapy and ASCT.
- ECOG performance status ≤2.
- Not pregnant and willing to use contraception
- For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Smoldering Multiple Myeloma.
- Monoclonal gammopathy of undetermined significance.
- Waldenströms Macroglobulinemia
- Plasma cell leukemia.
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
- 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 with minimal risk of recurrence per investigator.
- For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months...
- For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative...
- Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
- Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in...
The study team makes the final eligibility decision.
Where it's taking place
- Jupiter, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Houston, Texas, United States
- Benowa, Queensland, Australia
- Fitzroy, Victoria, Australia
- Melbourne, Victoria, Australia
- Richmond, Victoria, Australia
- Graz, Styria, Austria
- Rankweil, Vorarlberg, Austria
- Salzburg, Austria
- Vienna, Austria
- Ottignies, Brabant Wallon, Belgium
- Gilly, Hainaut, Belgium
- Roeselare, West-vlaanderen, Belgium
+ 96 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jupiter, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 110 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.