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New combo tackles resistant myeloma in early trial

NCT ID NCT05391750

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests two drugs—venetoclax and tocilizumab—in people with a specific type of multiple myeloma (t(11;14)) that has come back or stopped responding to treatment. The study includes both African American and non-African American participants to see how safe the combination is and what dose works best. Only 7 people are enrolled, so the focus is on safety and side effects, not yet on curing the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Venetoclax (a drug that blocks Bcl-2 protein) and tocilizumab (a monoclonal antibody that blocks interleukin-6 receptor)
What this could lead to
If successful, this could point toward a new combination treatment for a specific type of multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is a very early, small phase 1 trial with only 7 participants, so results may not apply broadly. The main goal is safety and dosing, not effectiveness, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

7 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Exclusion Criteria: Subject exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: * 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: * Adequately treated in situ carcinoma of the cervix uteri, * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, * 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: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.