TAlquetamab and BeLantamab Mafodotin in Relapsed/Refractory Multiple Myeloma (TaBleMM)

Starting soon · Phase 1

Conditions studied: Relapse Multiple Myeloma, Refractory Multiple Myeloma

In brief

This is a Phase 1, open-label dose escalation study evaluating the safety and clinical efficacy of Talquetamab in combination with Belantamab mafodotin for a time-limited interval followed by Belantamab mafodotin and Pomalidomide maintenance. The study will enroll subjects with Multiple Myeloma that have previously been treated with at least one prior line of therapy and have been treated with IMiDs, proteasome inhibitors, and anti-CD38 therapies either in combination or as single agent and are relapsed or are refractory to, or intolerant of, established therapies with clinical benefit in Multiple Myeloma. Talquetamab will be administered with step up dosing on day 1, 3, 5 with or without day 7 pending target dose (TD1) of Talquetamab (Tal) in dose level. Two weeks after TD1, patients will enroll on C1D1 of Tal (TD2) with Belantamab (Bela). Tal will subsequently be dosed every two weeks. Bela will be administered every 8 weeks on D1 of odd numbered cycles or until resolution of any ocular toxicities to grade 1 or better. After 6 cycles of induction, patients may transition to Bela/Pom maintenance.

Key facts

Study ID

NCT07720843

Run by

Montefiore Medical Center

People needed

50

Starts

2026-09-01

Expected to finish

2032-03-01

Last updated by the study team

2026-07-22

Who can join

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

You may qualify if…

• Male or Female subjects > 18 years of age
• Be willing and able to provide written informed consent prior to any protocol-related procedures including screening evaluations.
• Must meet 2014 International Myeloma Working Group (IMWG) guideline for diagnosis of Multiple Myeloma (and not smouldering myeloma) Dose Escalation: Participants in dose escalation must have measurable disease as defined by IMWG criteria, or have active bone findings on PET/CT or >1 measurable plasmacytoma that can be monitored on other imaging modalities.
• Dose Expansion: Participants must have measurable disease by IMWG criteria.
• Have been previously treated with at least 1 prior line of MM therapy and have previously been exposed to an Immunomodulatory Drug (IMiD), PI, and CD38 either in combination or as single agents and are relapsed/refractory or intolerant of prior therapies.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• Must have adequate organ and hematologic function as defined:
• Absolute Neutrophil Count (ANC) > 1000 in the absence of growth factor support (granulocyte colony stimulating factor [GSCF] within 7 days or pegylated granulocyte colony stimulating factor [peg-G-CSF] within 14 days)
• Hemoglobin > 8 g/dL.
• Platelet Count > 75 x10\^9/L in the absence of transfusion support within 7 days.
• Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤2.5 × upper limit of normal (ULN); bilirubin ≤1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin level <3.0 × ULN
• Estimated glomerular filtration rate (eGFR) > 30 as calculated by the Modified Diet in Renal Disease (MDRD) formula. All prior treatment-related toxicities (as defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v6.0) must be < Grade 1 at the time of enrollment, except for alopecia. Spot urine (albumin/creatinine ratios) < 500 mg/g (56mg/mmol) OR urine dipstick Negative/trace (if > + only eligible if confirmed <500 mg/kg [56mg/mmol] by albumin/creatinine ratio [spot urine from first void])
• Sex and contraceptive/barrier requirements:
• Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) OR
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and for at least 4 months after the last dose of study intervention, and agrees not to 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.
• A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before dosing on Cycle 1 Day 1 and agree to use a highly effective method of contraception during the study and for 4 months after the last dose of belantamab mafodotin.
• 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 an early undetected pregnancy.
• Nonchildbearing potential is defined as follows (by other than medical reasons):
• ≥45 years of age and has not had menses for >1 year
• Participants who have been amenorrheic for <2 years without history of a 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 participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this trial:
• A subject who meets any of the following criteria must not be enrolled on the study:
• Diagnosis of any of the following:
• Amyloidosis
• Plasma Cell Leukemia
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Myelodysplastic Syndrome, Myeloproliferative Neoplasia, or any other primary hematologic malignancy concurrent with Multiple Myeloma
• Any other history of malignancy other than Multiple Myeloma deemed at high risk of recurrence during study. Indolent cancers (e.g. prostate cancer without radiographic evidence of disease or history of resected local breast cancer on long term hormonal therapy) are acceptable.
• Treatment with any of the following:
• Systemic anticancer therapy < 14 days prior to first dose of study related therapy (Step-Up Dose 1), or <30 days for monoclonal antibodies (e.g. anti-CD38 antibodies). mAb for serious conditions unrelated to MM, such as COVID, may be permitted but need to be discussed with the medical monitor.
• Limited field radiotherapy < 7 days or extended field radiotherapy < 8 weeks prior to C1D1
• Major surgery < 4 weeks of the first dose of study drug on C1D1
• Any live or attenuated vaccines within 30 days of C1D1
• History of refractoriness to Talquetamab or Belantamab mafodotin
• Participants who received < 3 cycles of Talquetamab time limited therapy such as for bridging to other therapies without evidence of disease progression on treatment will be considered eligible after discussion with medical monitor.
• Active central nervous system involvement of disease, unless they are clinically stable for > 4 weeks after completing treatment prior to screening (a brain and/or other anatomic regions with CNS involvement MRI within 1 month of enrollment is required).
• Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin or any other components of the study treatment.
• Any of the following cardiovascular events within 6 months prior to C1D1:
• Known heart failure with reduced left ventricular ejection fraction < 45%
• Congestive heart failure New York Heart Association Class III or IV
• Unstable angina pectoris
• Unstable symptomatic ischemic heart disease
• Myocardial infarction
• Uncontrolled hypertension despite appropriate medical therapy
• Ongoing symptomatic cardiac arrhythmias > grade 2

Full record on ClinicalTrials.gov

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