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Plasma Cell LeukemiaPhase 2NCT07605416

Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial

A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection and Bone Marrow Aspiration in people with Plasma Cell Leukemia, run by National Cancer Institute (NCI) at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Plasma Cell Leukemia
What is being tested?
Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection and Bone Marrow Aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
11 sitesUnited States
Study dates
20 Apr 2027to 6 Nov 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of primary plasma cell leukemia according to IMWG criteria defined as 5% or greater circulating plasma cells at the time of initial diagnosis
  • Measurable disease at the time of initial diagnosis of at least one of the following as defined by IMWG criteria:
  • Serum monoclonal protein ≥ 0.5 g/dL or
  • Urine monoclonal protein ≥ 200 mg/24 hours (h) or
  • Serum free light chain (FLC) assay: Serum free light chain ≥ 100 mg/L and abnormal serum free light chain ratio
  • Age 18 - 80 years
Show all 47Show fewer
  • Prior treatment:
  • ≤ 1 cycle of induction treatment based on physician/investigator discretion
  • No history of severe allergic reaction (including erythema nodosum) to lenalidomide or other prior immunomodulatory imide drug (IMiD) therapy
  • No history of clinically significant cardiopulmonary disease resulting from prior proteosome inhibitor therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn, before study entry, the following criteria must be met
  • Female of childbearing potential (FCBP) is a female who: 1) has achieved menarche (first menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries), or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months). * Female of childbearing potential (FCBP):
  • Must use a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency during the intervention and agrees to not donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention
  • Given the risk of teratogenicity with immunomodulatory drugs (IMiD), females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to, and again within 24 hours of starting lenalidomide, and must either commit to continued abstinence from heterosexual intercourse or being two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must agree to use latex condom during sexual contract with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum frequency of 28 days about pregnancy precautions and risk of fetal exposure
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy
  • Non-childbearing potential is defined as follows (by other than medical reasons):
  • ≥ 45 years of age and has not had menses for > 1 year
  • Patients who have been amenorrhoeic for < 2 years without history of hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure
  • Male patients must agree to use an adequate method of contraception for the duration of the study and for 6 months afterwards.
  • Male participants: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of altered sperm:
  • Refrain from donating sperm, PLUS, either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR
  • Must agree to use contraception/barrier as detailed below:
  • Agree to use a male condom, even if they have undergone successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of < 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females)
  • Patients may not have polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, Waldenström's macroglobulinemia, or symptomatic amyloidosis. Amyloidosis found in skin or lymph nodes ("non-vital organs"), or incidental observation of amyloidosis on bone marrow biopsy, are permissible
  • Clinically significant adverse effects from any prior oncologic treatment (e.g., prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the investigator
  • Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • No patients known to have cardiac risk factors defined by any of the following criteria:
  • Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within two (2) months of screening
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system
  • Uncontrolled hypertension, defined as persistently elevated blood pressure (BP) meeting Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0 for ≥ grade 3 despite medical intervention
  • Patients with congenital long QT syndrome, Fridericia's formula-corrected QT interval (QTcF) interval QTcF > 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF])
  • Left ventricular ejection fraction < 40%
  • No significant neuropathy ≥ grade 3 or grade 2 neuropathy with pain at baseline
  • No known allergies, hypersensitivity, or intolerance to daratumumab and hyaluronidase-fihj, carfilzomib, lenalidomide, or dexamethasone
  • No known medical condition causing an inability to swallow oral formulations of agents
  • No major surgery within < 2 weeks prior to registration or who have not recovered from the side effects of surgery
  • Contraindication to any concomitant medication, including antivirals or anticoagulation
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (or ≥ 500/mm^3 if due to underlying disease)
  • Total bilirubin ≤ 2 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)
  • Calculated (calc.) creatinine clearance ≥ 30 mL/min by Modification of Diet in Renal Disease (MDRD)

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

United States11 sites, 11 recruiting

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Hana F. Safah

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Hamza Hassan

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Hani Hassoun

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Hani Hassoun

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Caitlin Costello

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Hani Hassoun

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Hani Hassoun

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Terri L. Parker

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Hani Hassoun

    Recruiting

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Terri L. Parker

    Recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Douglas W. Sborov

    Recruiting

Other trials in United States

About this study

Official title: Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial

This phase II trial compares standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone to consolidation with teclistamab following standard induction therapy and autologous hematopoietic stem cell transplant for improving overall survival of patients with plasma cell leukemia. Consolidation therapy is treatment given after initial therapy to kill any cancer cells that may remain in the body. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Carfilzomib inhibits protein complexes called proteasomes, which inhibits cancer cell growth and leads to cancer cell death. Lenalidomide may help kill cancer cells and prevents the growth of blood vessels that cancer cells need to survive. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving teclistamab as consolidation therapy after induction and autologous hematopoietic stem cell transplant may improve survival outcomes in patients with plasma cell leukemia, compared to standard consolidation with daratumumab, carfilzomib, lenalidomide, and dexamethasone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if quadruplet induction therapy followed by autologous stem cell transplantation, consolidation with teclistamab, a BCMA-targeted, T-cell redirecting bispecific antibody, and doublet maintenance treatment will improve overall survival compared to those receiving standard of care consolidation therapy (i.e. daratumumab, carfilzomib, lenalidomide, and dexamethasone [D-KRd]).

SECONDARY OBJECTIVES:

  1. To evaluate the progression free survival of quadruplet induction, autologous stem cell transplantation, consolidation, and doublet maintenance therapy.

II. To evaluate the safety of quadruplet induction, autologous stem cell transplantation, consolidation, and doublet maintenance therapy.

III. To evaluate response rates per International Myeloma Working Group (IMWG) criteria (overall response rate, partial response, very good partial response, complete response, stringent complete response).

EXPLORATORY OBJECTIVE:

  1. To evaluate minimal residual disease negativity by next generation sequencing (10^-5 and 10^-6) after induction, autologous stem cell transplant, consolidation, and after 1 and 2 years of maintenance treatment.

OUTLINE:

INDUCTION THERAPY (CYCLES 1-4): Patients receive daratumumab and recombinant human hyaluronidase (daratumumab and hyaluronidase-fihj) subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1 and 2 and days 1 and 15 of cycles 3 and 4, carfilzomib intravenously (IV) on days 1, 8, and 15 of each cycle, lenalidomide orally (PO) once daily (QD) on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

AUTOLOGOUS STEM CELL TRANSPLANT: Within 60 days of completing induction therapy, patients undergo stem cell mobilization using recombinant granulocyte colony-stimulating factor SC and plerixafor SC followed by stem cell collection according to standard of care. Patients then receive melphalan IV followed by autologous hematopoietic stem cell transplant (autoHSCT).

CONSOLIDATION THERAPY (CYCLES 5-12): Patients are randomized to 1 of 2 arms for consolidation therapy, to start within 120 days of autoHSCT.

ARM 1: Patients receive daratumumab and hyaluronidase-fihj SC on days 1 and 15 of cycles 5-6 and on day 1 of cycles 7-12, carfilzomib IV on days 1, 8, and 15 of each cycle, lenalidomide on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive teclistamab SC on days 1, 3, 7, and 15 of cycle 5, once weekly thereafter for cycles 5-6, every 2 weeks in cycles 7-10, and every 4 weeks in cycles 11-12. Cycles repeat every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY (CYCLES 13-36): Within 60 days of completing consolidation therapy, patients receive carfilzomib IV on days 1 and 15 of each cycle and lenalidomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Patients also undergo transthoracic echocardiography (TTE) at screening and then as clinically indicated and undergo bone marrow biopsy and aspiration, collection of blood samples, and fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT), magnetic resonance imaging (MRI), and/or CT throughout the trial.

After completion of study treatment, patients are followed up every 3 or 6 months for up to 5 years from registration.

Being tested
Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Carfilzomib
Medical subject headings
Leukemia, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant

    Undergo autoHSCT

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • CarfilzomibDrug

    Also called Carfilnat, CFZ, Kyprolis, PR 171

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT and/or CT

  • Daratumumab and Recombinant Human HyaluronidaseDrug

    Also called DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab and Hyaluronidase

    Given SC

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Undergo FDG PET/CT

  • LenalidomideDrug

    Also called CC 5013, CC-5013, CC5013, CDC 501

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MelphalanDrug

    Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard

    Given IV

  • PlerixaforDrug

    Also called AMD 3100, AMD-3100, AMD3100, JM-3100

    Given SC

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Recombinant Granulocyte Colony-Stimulating FactorBiological

    Also called Recombinant Colony-Stimulating Factor 3, rhG-CSF

    Given SC

  • Stem Cell IsolationProcedure or surgery

    Also called Isolation, Stem Cell, Stem Cell Collection, Stem Cell Recovery

    Undergo stem cell collection

  • TeclistamabDrug

    Also called JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv

    Given SC

  • Transthoracic Echocardiography TestProcedure or surgery

    Also called TRANSTHORACIC ECHOCARDIOGRAPHY, TTE

    Undergo TTE

Study groups in NCT07605416
Study groupRoleWhat they receive
Arm 1 (induction, autoHSCT, D-KRd, maintenance)Active comparatorSee Detailed Description.
Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Carfilzomib; Procedure: Computed Tomography; Drug: Daratumumab and Recombinant Human Hyaluronidase; Drug: Dexamethasone; Other: Fludeoxyglucose F-18; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Drug: Melphalan; Drug: Plerixafor; Procedure: Positron Emission Tomography; Biological: Recombinant Granulocyte Colony-Stimulating Factor; Procedure: Stem Cell Isolation; Procedure: Transthoracic Echocardiography Test
Arm 2 (induction, autoHSCT, teclistamab, maintenance)ExperimentalSee Detailed Description.
Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Carfilzomib; Procedure: Computed Tomography; Drug: Daratumumab and Recombinant Human Hyaluronidase; Drug: Dexamethasone; Other: Fludeoxyglucose F-18; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Drug: Melphalan; Drug: Plerixafor; Procedure: Positron Emission Tomography; Biological: Recombinant Granulocyte Colony-Stimulating Factor; Procedure: Stem Cell Isolation; Drug: Teclistamab; Procedure: Transthoracic Echocardiography Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    The time to event outcome of overall survival will be evaluated and compared using a log-rank test to compare differences between arms. OS distributions will be evaluated graphically using the methods of Kaplan and Meier, along with estimation of the 3-year OS rates with corresponding 95% confidence intervals and other time points of interest. In a secondary manner, Cox regression models will also be used to evaluate differences in OS between treatment arms when adjusting for factors of interest as well as stratifying on the stratification factors including prior treatment status and t(11;14) status.

    Measured: From randomization to the time of death due to any cause, assessed up to 5 years

Secondary outcomes (3)

  1. Incidence of adverse events

    Adverse events (AEs) will be summarized per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, and where toxicities will be defined as adverse events that are deemed to be at least possibly treatment-related (i.e., attribution of "possibly", "probably", or "definite"). Note that some AEs will be defined using other criteria where specified. The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized across all patients for the induction phase, and by treatment arm for the consolidation and maintenance phases of treatment. Frequency tables and graphical evaluations of AEs and treatment-related AEs will be summarized and evaluated to assess if there are any patterns or differences in the rates or types of AEs including, but not limited to, AEs of special interest including cytokine release syndrome, neurotoxicity, and second primary malignancies.

    Measured: Up to 5 years

  2. Progression free survival (PFS)

    Will use Kaplan-Meier analyses and Cox regression models to evaluate this endpoint and how the PFS distributions differ between the treatment arms.

    Measured: From randomization to the time of progression and/or death due to any cause, assessed up to 5 years

  3. Overall response rate

    Overall response rate will be summarized for each of the treatment arms and defined as the number of patients who achieve at least a partial response to therapy divided by the total number of patients treated on that arm. Will summarize the incidence and depth of objective response both post-induction as well as post-consolidation. Response rates will be calculated along with 95% binomial confidence intervals for each of the t(11;14) subjects and treatment arms.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start20 Apr 2027 (estimated)
  3. Primary completion6 Nov 2032 (estimated)
  4. Study completion6 Nov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07605416
Sponsor's protocol ID
NCI-2026-03676
Other IDs
NCI-2026-03676, A062401, A062401, U10CA180821
Status last verified
Aug 2026
First submitted
22 May 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection and Bone Marrow Aspiration in people with Plasma Cell Leukemia, run by National Cancer Institute (NCI) at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From randomization to the time of death due to any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07605416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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