Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma

In brief

This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.

Key facts

Study ID: NCT05231629
Run by: University of Alabama at Birmingham
People needed: 300
Starts: 2023-12-13
Expected to finish: 2029-12-01
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age>18 years with no upper age limit
Newly diagnosed multiple myeloma with indication for initiation of therapy.
ECOG performance status 0-2
No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 and/or lenalidomide (up to 21 days of therapy) administered for no longer than 4 weeks prior to enrollment (pre induction). If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available.
Measurable disease meeting at least one of the following criteria (at screening or prior to pre induction):
Serum monoclonal (M) protein ≥1.0 g/dl (≥0.5 g/dl if IgA, IgD, IgE or IgM multiple myeloma)
≥ 200 mg of M protein/24h in the urine
Difference between affected and unaffected free light chain ≥10 mg/dL with abnormal kappa to lambda ratio.
Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment
Hemoglobin ≥7 g/dL (≥4.65 mmol/L; without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted)
Platelets ≥75×10\^9/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×10\^9/L in participants in whom
50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test)
Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated G CSF)
AST and ALT ≤2.5×ULN
eGFR ≥30 mL/min based on Modified Diet in Renal Disease Formula calculation or creatine clearance measured by a 24-hour urine collection
Total bilirubin ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required)
Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
A woman of childbearing potential must have a negative highly-sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
A woman must be
Not of childbearing potential, or
Of childbearing potential and
Practicing true abstinence; or
Have a sole partner who is vasectomized; or
Practicing ≥1 highly-effective, user-independent method of contraception
A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study treatment

You may not qualify if…

Diagnosis of Plasma cell leukemia, primary light chain amyloidosis, POEMS, or Waldenstrom's macroglobulinemia.
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab Investigator's Brochure and appropriate package inserts)
Prior or concurrent exposure to any of the following:
Teclistamab or any anti-BCMA therapy
Daratumumab or any anti-CD38 therapy
Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
Investigational vaccine within 4 weeks
Live, attenuated vaccine within 4 weeks before randomization.
Radiotherapy within 14 days or focal radiation within 7 days
Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
Cytotoxic therapy within 14 days
PI therapy within 14 days
IMiD agent therapy within 14 days
Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are:
Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured
Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
Noninvasive cervical cancer treated within the last 24 months that is considered completely cured
Localized prostate cancer (N0M0):
With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance
With a Gleason score of 3+4 that has been treated >6 months prior to full study screening and considered to have a very low risk of recurrence, or
History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.
Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence
Other malignancy that is considered cured with minimal risk of recurrence
Stroke or seizure within 6 months prior to signing ICF.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
Columbia University — New York, New York, United States (enrolling)
Oregon Health and Science University — Portland, Oregon, United States (enrolling)
Vanderbilt University — Nashville, Tennessee, United States (enrolling)
University of Texas Southwestern — Dallas, Texas, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
University of Washington — Seattle, Washington, United States (enrolling)
University of Wisconsin - Carbone — Madison, Wisconsin, United States (enrolling)
Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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