Recurrent Plasma Cell MyelomaPhase 1NCT05391750

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

A Phase 1 study testing Tocilizumab and Venetoclax in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by Emory University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
What is being tested?: Tocilizumab and Venetoclax
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2022to 12 Feb 2028
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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:

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

To determine the dose limiting toxicity (DLT), safety profile, and the recommended phase 2 dose (RPTD) of venetoclax and tocilizumab when administered in subjects with relapsed and recurrent (RR) multiple myeloma t(11;14) (MM).

SECONDARY OBJECTIVES:

I.To evaluate the preliminary efficacy data regarding the effect of venetoclax and tocilizumab by objective response rate per IMWG criteria.

II. To evaluate the effect of chronic tocilizumab administration on venetoclax exposure.

TERTIARY/EXPLORATORY OBJECTIVES:

To evaluate the preliminary efficacy data regarding the effect of venetoclax and tocilizumab by time to response (TTR), time to disease progression (TTP), duration of response (DOR), progression free survival (PFS) and overall survival (OS).

II. To measure the effect of IL6 receptor blockade on ex vivo venetoclax sensitivity.

III. To evaluate the cell populations in the bone marrow of responders versus non-responders as well as the effect of IL6 receptor blockade on those populations.

IV. To evaluate the expression of B cell markers on venetoclax sensitive myeloma.

To determine the expression of key BCL2 family members with and without IL6 receptor blockade.

VI. To correlate differences in somatic mutations, structural alterations, gene expression and chromatin accessibility with venetoclax response.

OUTLINE: This is a dose-escalation study of venetoclax and tocilizumab.

Patients receive tocilizumab intravenously (IV) on day -7 of cycle 1, and on day 1 of subsequent cycles. Patients also receive venetoclax orally (PO) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks, then every 6 months thereafter.

Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Being tested: Tocilizumab, Venetoclax
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TocilizumabBiological
Also called Actemra, Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer, MRA, R-1569
Given IV
VenetoclaxDrug
Also called ABT-0199, ABT-199, ABT199, GDC-0199
Given PO

Study groups in NCT05391750
Study group	Role	What they receive
Treatment (venetoclax, tocilizumab)	Experimental	Patients receive tocilizumab IV on day -7 of cycle 1, and on day 1 of subsequent cycles. Patients also receive venetoclax PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Tocilizumab; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum tolerated dose (MTD)
The MTD for each arm is selected based on isotonic regression27, using the shiny app BOINComb (http://www.trialdesign.org). The dose is selected as the MTD for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level is selected when the isotonic estimate is lower than the target toxicity rate; the lower dose level is selected when the isotonic estimate is greater than or equal to the target toxicity rate.
Measured: Completion of cycle 1 (each cycle is 21 days)

Secondary outcomes (8)

Incidence of adverse events (AEs)
AEs, related AEs, serious (S)AEs, related SAEs, and AEs leading to interruptions and/or discontinuation of study drug will be analyzed descriptively, using frequencies and percentages.
Measured: Up to 30 days post-treatment
Overall response rate (ORR)
ORR will be calculated with an exact 95% confidence interval (CI) for each arm, using the Clopper-Pearson method.
Measured: Up to 5 years
Complete response rate
Complete response rate will be calculated with an exact 95% CI for each arm, using the Clopper-Pearson method.
Measured: Up to 5 years
Time to response (TTR)
TTR will be estimated using the Kaplan-Meier method. Median TTR will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Measured: From date of receipt of study treatment to date of treatment response, where those not responding are censored at date of last follow-up or death from any cause, assessed up to 5 years
Time to disease progression (TTP)
TTP will be estimated using the Kaplan-Meier method. Median TTP will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Measured: From date of receipt of study treatment to date of disease progression, where those not progressing or have died are censored at date of last follow-up or death from any cause, assessed up to 5 years
Duration of response (DOR)
Median DOR will be reported, along with the 25th and 75th percentiles.
Measured: From date of treatment response to date of disease progression, assessed up to 5 years
Progression-free survival (PFS)
PFS will be estimated using the Kaplan-Meier method. Median PFS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Measured: From date of receipt of study treatment to date of disease progression or death from any cause, where those alive without are censored at date of last follow-up, assessed up to 5 years
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method. Median OS will be reported, along with a 95% confidence interval estimated using the Brookmeyer-Crowley method.
Measured: From date of receipt of study treatment to date of death from any cause, where those alive without are censored at date of last follow-up, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202212 Feb 2028

First posted26 May 2022
Study start19 Oct 2022
Primary completion12 Feb 2027 (estimated)
Study completion12 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Recurrent Plasma Cell MyelomaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05391750
Sponsor's protocol ID: STUDY00002448
Other IDs: NCI-2021-02510, STUDY00002448, WINSHIP5273-21, P30CA138292
Status last verified: Feb 2026
First submitted: 13 Apr 2022
Last updated: 17 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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