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

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT05391750
Trial Phases:	Phase I	Protocol IDs:	WINSHIP5273-21 (primary) NCI-2021-02510 STUDY00002448
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05391750

Summary

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.

Objectives

PRIMARY OBJECTIVE:
I. 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 overall response rate (ORR) of venetoclax in combination with tocilizumab in relapsed and refractory myeloma (RRMM).
II. To determine the time to response (TTR), time to disease progression (TTP), duration of response (DOR), progression free survival (PFS) and overall survival (OS) with RRMM patients treated with venetoclax in combination with tocilizumab.
III. To evaluate the effect of chronic tocilizumab administration on venetoclax exposure.

TERTIARY/EXPLORATORY OBJECTIVES:
I. To measure the effect of IL6 receptor blockade on ex vivo venetoclax sensitivity.
II. To evaluate the cell populations in the bone marrow of responders versus [vs.] non-responders as well as the effect of IL6 receptor blockade on those populations.
III. To evaluate the expression of B cell markers on venetoclax sensitive myeloma.
IV. To determine the expression of key BCL2 family members and the effect of IL6 receptor blockade on this expression.
V. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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