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

Recruiting now · Phase 2

Conditions studied: Plasma Cell Leukemia

In brief

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.

Key facts

Study ID

NCT07605416

Run by

National Cancer Institute (NCI)

People needed

74

Starts

2027-04-20

Expected to finish

2032-11-06

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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:

Where it is running

• Alliance for Clinical Trials in Oncology — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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