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New treatment option for High Risk Newly Diagnosed Multiple Myeloma
Official title Horizon Two: HR NDMM (MMRC-100)
ClinicalTrials.gov ID: NCT07053436
What this study is testing
What is Bispecific Monoclonal Antibody and Triplet Therapy?
Bispecific Monoclonal Antibody and Triplet Therapy is an investigational medicine, being studied as a potential treatment for high risk newly diagnosed multiple myeloma.
Also referred to as Linvoseltamab.
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
- The Multiple Myeloma Research Consortium (MMRC) Horizon Two trial is a master protocol, multi-center, phase II randomized adaptive platform trial designed to efficiently evaluate multiple investigational therapies in high-risk newly diagnosed multiple myeloma patients using an integrated and patient-centric clinical research platform that enables longitudinal learning and sharing of knowledge and investigates multiple novel therapeutic strategies within one trial platform.
- 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 18 and older
You may be able to join if
- Voluntarily agree to participate by giving written informed consent -≥18 years of age
- Symptomatic and transplant eligible newly diagnosed multiple myeloma histologically confirmed per IMWG criteria that is high-risk as defined by at...
- Del(17p) (CCF ≥ 20%, by analyses conducted on CD138-positive/purified cells) and/or TP53 mutation assessed by NGS
- One of these translocations-t(4;14) or t(14;16) or t(14;20)-co-occurring with +1q and/or del(1p32)
- Monoallelic del(1p32) along with +1q, or biallelic del(1p32)
You likely can't join if
- Major concurrent illness or organ dysfunction including but not limited to the following:
- POEMS syndrome
- Symptomatic major organ involvement AL amyloidosis
- History of allergy or known hypersensitivity to any of the trial therapies or any of their excipients, or contraindication to any of the trial...
- Complete spinal cord compression or CNS involvement
- Known leptomeningeal disease
See the full eligibility criteria
- Voluntarily agree to participate by giving written informed consent -≥18 years of age
- Symptomatic and transplant eligible newly diagnosed multiple myeloma histologically confirmed per IMWG criteria that is high-risk as defined by at least one of the following:
- Del(17p) (CCF ≥ 20%, by analyses conducted on CD138-positive/purified cells) and/or TP53 mutation assessed by NGS
- One of these translocations-t(4;14) or t(14;16) or t(14;20)-co-occurring with +1q and/or del(1p32)
- Monoallelic del(1p32) along with +1q, or biallelic del(1p32)
- High β2M (≥5.5 mg/dL) with normal creatinine (\<1.2 mg/dL)
- Presence of extra-medullary disease non-contiguous with bone at diagnosis (by PET-CT or Whole Body MRI)
- Primary plasma cell leukemia (circulating plasma cells \> 5% at diagnosis)
- No more than 2 cycles of NCCN listed induction therapy for multiple myeloma
- Measurable disease, per IMWG criteria, at time of diagnosis defined as one of the following:
- Serum M-protein at diagnosis ≥ 0.5g/dL (0.3 g/dL or above if IgA subtype)
- Urine M-protein ≥ 200 mg/24hours
- Serum free light chain difference \> 100 mg/L
- Plasmacytoma ≥ 2cm
- Bone marrow involvement ≥ 30%
- ECOG performance status of 0-2
- Adequate organ function, as indicated by the following laboratory values:
- Adequate hematological function, defined as ANC ≥ 1000/µL, platelet count ≥ 75,000/µL, and hemoglobin ≥ 8 g/dL (transfusion and/or growth factor support is allowed for hematologic parameters as long as the investigator...
- Adequate hepatic function, defined as total bilirubin level ≤ 1.5 x institutional upper limit of normal (IULN) except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct...
- Adequate renal function, defined as calculated creatinine clearance ≥ 30 mL/min per institutional standard (assessment method should be recorded, measured or C-G acceptable)
- Persons of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of trial medication). Non-childbearing potential for a person assigned as female at birth is...
- Amenorrheic for \> 2 years without a hysterectomy and/or oophorectomy and follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
- Status is post-hysterectomy, -oophorectomy, or -tubal ligation
- Persons of childbearing potential must be willing to use highly effective contraceptive measures during sexual contact with a person assigned as male at birth starting with the Screening visit through 90 days after last...
- Persons assigned as male at birth with a partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the...
- Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional...
- Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessments of the investigational arms are eligible for this trial.
- Known HIV infection and on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated.
- History of hepatitis C virus (HCV) infection must have been treated and cured. For patients with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Willing and able to comply with the requirements of the protocol.
- Major concurrent illness or organ dysfunction including but not limited to the following:
- POEMS syndrome
- Symptomatic major organ involvement AL amyloidosis
- History of allergy or known hypersensitivity to any of the trial therapies or any of their excipients, or contraindication to any of the trial therapies as outlined in the local prescribing information (e.g., United...
- Complete spinal cord compression or CNS involvement
- Known leptomeningeal disease
- Allogeneic tissue/solid organ transplant recipients with chronic GVHD requiring steroid equivalent dose of \> 20 mg prednisone
- Active infection requiring treatment
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not...
- Psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- Legally incapacitated or has limited legal capacity
- Persons who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; New York, New York, United States and 1 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.