Is NCT07053436 recruiting in St Louis, MO?

Yes, NCT07053436 is currently recruiting participants at its St Louis, MO location. This high risk newly diagnosed multiple myeloma clinical trial is actively enrolling qualified participants.

Is participation in this St Louis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

High Risk Newly Diagnosed Multiple Myeloma Clinical Trial in St Louis, MO

Q: How do I join the high risk newly diagnosed multiple myeloma clinical trial in St Louis?

To join this clinical trial in St Louis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This High Risk Newly Diagnosed Multiple Myeloma Study in St Louis

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.

Sponsor: Multiple Myeloma Research Consortium

Who Can Participate

Inclusion 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 deems the patient otherwise fit for screening)

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 bilirubin ≤1.5 x IULN is required), AST ≤ 2.5 x IULN, and ALT ≤ 2.5 x IULN

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 defined as 1 of the following: --≥ 45 years of age and has not had menses for \>1 year

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 dose of trial medication. --Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.

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 last dose of trial medication is received. Persons assigned as male at birth with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. --Note: Abstinence is acceptable if this is the established and preferred contraception method for the participant.

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 Classification. To be eligible for this trial, participants should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.

Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy 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.

Exclusion Criteria

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 States Prescribing Information \[USPI\])

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 in the best interest of the participant to participate, in the opinion of the treating investigator

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT07053436) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

High Risk Newly Diagnosed Multiple Myeloma Treatment Options in St Louis, MO

If you're searching for high risk newly diagnosed multiple myeloma treatment options in St Louis, MO, this clinical trial (NCT07053436) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced high risk newly diagnosed multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all high risk newly diagnosed multiple myeloma clinical trials near you to find additional studies recruiting in your area.

High Risk Newly Diagnosed Multiple Myeloma Clinical Trial in St Louis, MO

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