NCT05391750Active, not recruitingPhase 1

Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma

A Phase 1 Study Evaluating the Safety of Venetoclax and Tocilizumab in African American and Non-African American Subjects With Relapsed or Refractory t(11;14) Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

This phase I trial finds out the best dose and side effects of venetoclax and tocilizumab in treating patients with t(11;14) multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Tocilizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Tocilizumab is used to treat side effects from immune therapy in patients with myeloma. Giving venetoclax and tocilizumab may kill more cancer cells.

Status (registry): Active, not recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 7 (actual)
First submitted: 13 Apr 2022
Start date: 19 Oct 2022
Primary completion date: 12 Feb 2027
Lead sponsor: Emory University
Diseases: Multiple myeloma
NCT number: NCT05391750

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 7
From 19 Oct 2022 to the primary completion date, 12 Feb 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Acute infection within 14 days prior to first dose of study drug requiring antibiotic, antifungal, or antiviral therapy
Diagnosis of fever and neutropenia within 1 week prior to first dose of study drug
- Subject has a cardiovascular disability status of New York Heart Association class \>= 3
- Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study
- Subject has a history of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions:
Strong or moderate CYP3A inhibitors, or
Strong or moderate CYP3A inducers
- Subject has received any of the following within 14 days prior to the first dose of study drug or has not recovered to less than a grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy: any anti-myeloma therapy including chemotherapy, radiotherapy, or investigational therapy, including targeted small molecule agents
- Subject has received prior treatment with a BCL-2 family inhibitor
- Subject is pregnant, parturient, or breastfeeding; deprived of freedom by judicial or administrative decision; hospitalized and unable to provide consent, or otherwise unable to provide consent
- Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the first dose of study drug
- Subject has received immunization with live vaccine within 60 days of dosing
- Recent corticosteroid therapy at a cumulative dose equivalent to \> 140 mg of prednisone or a single dose equivalent to \>= 40 mg of dexamethasone within 2 weeks prior to the first dose of study drug
- Subject's decision to not divulge the race

Other illness

Subject exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to:
Localized prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen (PSA) levels off treatment
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- Known human immunodeficiency viral (HIV) infection
- Active hepatitis B or C infection based on screening blood testing
- Subject is receiving other ongoing anti-myeloma therapy
- Subject has received any of the following within 7 days prior to the first dose of study drug:

Other

Adequately treated in situ carcinoma of the cervix uteri,
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin,

Criteria the registry did not label

Subject must be \>= 18 years of age Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of =\< 2
Diagnosis of multiple myeloma that requires treatment and has been previously treated with:
Has received at least 2 prior lines of therapy
Has had documented disease progression on or within 60 days after completion of the last therapy.
Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
Has received at least 2 consecutive cycles of a proteasome inhibitor (PI). Have MM positive for t(11;14) translocation as determined by an analytically validated fluorescence in-situ hybridization (FISH) assay per the central laboratory testing
- Subject must have had measurable disease at Screening, defined as any of the following:
Serum monoclonal protein \>= 1.0 g/dL (\>= 10 g/L) by protein electrophoresis, or
\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis, or
Serum immunoglobulin free light chain (FLC) \>= 10 mg/dL provided serum FLC ratio is abnormal
- Subjects with a history of autologous transplantation must have adequate peripheral blood counts as defined below, have recovered from any transplant related toxicity(s) and be \> 100 days post-autologous transplant (prior to first dose of study drug)
- Subjects must meet the following laboratory parameters, per laboratory reference range, at least once during the screening period:
Absolute neutrophil count (ANC) \>= 1000/uL (Subject may use granulocyte colony-stimulating factor \[G-CSF\] to achieve ANC eligibility criteria)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x upper limit of normal range (ULN)
Calculated creatinine clearance \>= 30 mL/min using a modified Cockcroft- Gault calculation or a 24-hour urine collection for creatinine clearance
Platelet count \>= 75,000 cells/mm3 and independent of transfusion for 2 weeks
Hemoglobin \>= 8.0 g/dL, subjects may not receive blood transfusion within 1 week to achieve hemoglobin eligibility criteria per investigator discretion
Total bilirubin =\< 1.5 x ULN; subjects with Gilbert's syndrome may have bilirubin \> 1.5 x ULN
- If female, subject must be:
Postmenopausal defined as:
- Age \> 55 years with no menses for 24 or more months without an alternative medical cause
- Age =\< 55 years with no menses for 24 or more months without an alternative medical cause
- AND an follicle stimulating hormone (FSH) level \> 40 IU/L. OR
Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) OR
A woman of childbearing potential (WOCP) practicing at least one protocol specified method of birth control starting at cycle 1 day 1 (or earlier) through at least 30 days after last dose of study drug
- Females of childbearing potential (must have negative results for pregnancy test performed:
At screening, on a serum or urine sample obtained within 28 days prior to the first study drug administration,
Prior to dosing, on a urine sample obtained on the first day of study drug dosing, if it has been \> 7 days since obtaining the serum pregnancy test results
Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined above) at screening do not require pregnancy testing
- Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status	Atlanta	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.