Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial
May 22, 2026 updated by: National Cancer Institute (NCI)
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
- Procedure: Biospecimen Collection
- Procedure: Magnetic Resonance Imaging
- Drug: Lenalidomide
- Drug: Dexamethasone
- Drug: Melphalan
- Procedure: Positron Emission Tomography
- Procedure: Bone Marrow Aspiration
- Biological: Recombinant Granulocyte Colony-Stimulating Factor
- Drug: Carfilzomib
- Drug: Plerixafor
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Procedure: Bone Marrow Biopsy
- Procedure: Stem Cell Isolation
- Other: Fludeoxyglucose F-18
- Procedure: Computed Tomography
- Drug: Teclistamab
- Drug: Daratumumab and Recombinant Human Hyaluronidase
- Procedure: Transthoracic Echocardiography Test
Detailed Description
PRIMARY OBJECTIVE:
I. 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:
I. 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:
I. 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.
Study Type
Interventional
Enrollment (Estimated)
74
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1 (induction, autoHSCT, D-KRd, maintenance)
See Detailed Description.
|
Undergo collection of blood samples
Other Names:
Undergo MRI
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Undergo PET/CT
Other Names:
Undergo bone marrow aspiration
Given SC
Other Names:
Given IV
Other Names:
Given SC
Other Names:
Undergo autoHSCT
Other Names:
Undergo bone marrow biopsy
Other Names:
Undergo stem cell collection
Other Names:
Undergo FDG PET/CT
Other Names:
Undergo PET/CT and/or CT
Other Names:
Given SC
Other Names:
Undergo TTE
Other Names:
|
|
Experimental: Arm 2 (induction, autoHSCT, teclistamab, maintenance)
See Detailed Description.
|
Undergo collection of blood samples
Other Names:
Undergo MRI
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Undergo PET/CT
Other Names:
Undergo bone marrow aspiration
Given SC
Other Names:
Given IV
Other Names:
Given SC
Other Names:
Undergo autoHSCT
Other Names:
Undergo bone marrow biopsy
Other Names:
Undergo stem cell collection
Other Names:
Undergo FDG PET/CT
Other Names:
Undergo PET/CT and/or CT
Other Names:
Given SC
Other Names:
Given SC
Other Names:
Undergo TTE
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: From randomization to the time of death due to any cause, assessed up to 5 years
|
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.
|
From randomization to the time of death due to any cause, assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of adverse events
Time Frame: Up to 5 years
|
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.
|
Up to 5 years
|
|
Progression free survival (PFS)
Time Frame: From randomization to the time of progression and/or death due to any cause, assessed up to 5 years
|
Will use Kaplan-Meier analyses and Cox regression models to evaluate this endpoint and how the PFS distributions differ between the treatment arms.
|
From randomization to the time of progression and/or death due to any cause, assessed up to 5 years
|
|
Overall response rate
Time Frame: Up to 5 years
|
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.
|
Up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minimal residual disease (MRD) negativity
Time Frame: At baseline, post-induction, post-transplant, post-consolidation, and post-maintenance
|
MRD negativity will be evaluated over the course of the trial when a bone marrow biopsy and aspirate is obtained to confirm complete response or better and will be summarized based on treatment arm and t(11;14) status.
Repeated measures models will also be used to evaluate changes over time along with graphical analyses to assess patterns or differences based on subgroup and/or treatment and how these relate to key therapeutic milestones.
Time-dependent covariate analyses will also be used to explore the relationship of this outcome and how these longitudinal outcomes may correspond to PFS and OS in these patients.
|
At baseline, post-induction, post-transplant, post-consolidation, and post-maintenance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Douglas W Sborov, Alliance for Clinical Trials in Oncology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
November 6, 2032
Study Completion (Estimated)
November 6, 2032
Study Registration Dates
First Submitted
May 22, 2026
First Submitted That Met QC Criteria
May 22, 2026
First Posted (Actual)
May 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 22, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Leukemia
- Multiple Myeloma
- Hemic and Lymphatic Diseases
- Leukemia, Plasma Cell
- Amino Acids, Peptides, and Proteins
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Investigative Techniques
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Carboxylic Acids
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Transplantation
- Glycoside Hydrolases
- Hydrolases
- Enzymes
- Enzymes and Coenzymes
- Polysaccharide-Lyases
- Carbon-Oxygen Lyases
- Lyases
- Piperidines
- Amino Acids
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Benzene Derivatives
- Diagnostic Techniques, Surgical
- Chemistry Techniques, Analytical
- Sulfonic Acids
- Sulfur Acids
- Spectrum Analysis
- Nitrogen Mustard Compounds
- Mustard Compounds
- Hydrocarbons, Halogenated
- Pregnadienetriols
- Deoxyglucose
- Deoxy Sugars
- Cell Transplantation
- Cell- and Tissue-Based Therapy
- Biological Therapy
- Phenylalanine
- Amino Acids, Aromatic
- Amino Acids, Cyclic
- Phthalimides
- Phthalic Acids
- Acids, Carbocyclic
- Piperidones
- Isoindoles
- Benzenesulfonates
- Arylsulfonates
- Arylsulfonic Acids
- Lenalidomide
- Dexamethasone
- Fluorodeoxyglucose F18
- Melphalan
- Calcium Dobesilate
- Hyaluronoglucosaminidase
- Biopsy
- Specimen Handling
- Magnetic Resonance Spectroscopy
- Stem Cell Transplantation
- carfilzomib
- dexamethasone 21-phosphate
- daratumumab
- plerixafor
- auricularum
- dexamethasone acetate
- pegylated granulocyte colony-stimulating factor
- ferric pyrophosphate
Other Study ID Numbers
- NCI-2026-03676 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180821 (U.S. NIH Grant/Contract)
- A062401 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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