Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial
Quadruplet Induction Followed by Teclistamab Consolidation and Doublet Maintenance in Patients With Primary Plasma Cell Leukemia: The QUANTUM Trial
3 other identifiers
interventional
74
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2026
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2026
CompletedFirst Posted
Study publicly available on registry
May 26, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2032
Study Completion
Last participant's last visit for all outcomes
November 6, 2032
May 26, 2026
May 1, 2026
6.4 years
May 22, 2026
May 22, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
From randomization to the time of death due to any cause, assessed up to 5 years
Secondary Outcomes (3)
Incidence of adverse events
Up to 5 years
Progression free survival (PFS)
From randomization to the time of progression and/or death due to any cause, assessed up to 5 years
Overall response rate
Up to 5 years
Other Outcomes (1)
Minimal residual disease (MRD) negativity
At baseline, post-induction, post-transplant, post-consolidation, and post-maintenance
Study Arms (2)
Arm 1 (induction, autoHSCT, D-KRd, maintenance)
ACTIVE COMPARATORSee Detailed Description.
Arm 2 (induction, autoHSCT, teclistamab, maintenance)
EXPERIMENTALSee Detailed Description.
Interventions
Undergo autoHSCT
Undergo collection of blood samples
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Given IV
Undergo PET/CT and/or CT
Given SC
Given PO
Undergo FDG PET/CT
Given PO
Undergo MRI
Given IV
Given SC
Undergo PET/CT
Given SC
Undergo stem cell collection
Given SC
Undergo TTE
Eligibility Criteria
You may qualify if:
- 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
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas W Sborov
Alliance for Clinical Trials in Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2026
First Posted
May 26, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
November 6, 2032
Study Completion (Estimated)
November 6, 2032
Last Updated
May 26, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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.