Venetoclax for Multiple Myeloma

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Utah /ID# 151397, Salt Lake City, UT
Multiple Myeloma+1 More
Venetoclax - Drug
Eligibility
18+
All Sexes
Eligible conditions
Multiple Myeloma

Study Summary

Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

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Eligible Conditions

  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Venetoclax will improve 4 primary outcomes and 16 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 2 years (Screening, Cycle 3 Day 1, and Confirmation of Stringent Complete Response [sCR]/Complete Response [CR]).

Day 1
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax
Maximum Plasma Concentration (Cmax) of Venetoclax
Time to Maximum Plasma Concentration (Peak Time, Tmax) of Venetoclax
Day 1
AUC from 0 to Infinity (AUC∞) of Carfilzomib
AUC from Time 0 to the Time of the Last Measurable Concentration (AUCt) of Carfilzomib
Clearance (CL) of Carfilzomib
Cmax of Carfilzomib
Terminal Elimination Half-life (t1/2) of Carfilzomib
Terminal Phase Elimination Rate Constant (β) of Carfilzomib
Year 2
Complete Response (CR) or Better Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Number of Participants with Adverse Events
Objective Response Rate (ORR) of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Very Good Partial Response (VGPR) or Better Response Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Year 2
Minimal residual disease (MRD)
Month 17
Duration of Overall Response (DOR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Objective response rate (ORR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Progression-free survival (PFS) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Time to Response (TTR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Time to progression (TTP) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Very Good Partial Response (VGPR) or Better Response Rate in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
Venetoclax + Carfilzomib + Dexamethasone

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Venetoclax is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Venetoclax + Carfilzomib + DexamethasonePart 1: Evaluate the safety and pharmacokinetic profiles while providing information to determine the appropriate doses of venetoclax and carfilzomib (VenKd) to be used in the VenKd combination in approximately 18 participants. The dose levels are Venetoclax 400 mg or 800 mg; Carfilzomib 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; Dexamethasone 40 mg Part 2: Further evaluate the safety and efficacy profile of the VenKd combination selected after completion of Part 1 in approximately 22 additional participants. Participants may discontinue Kd but may continue receiving venetoclax once daily (QD) as monotherapy. Part 3: Further evaluation of the efficacy of the VenKd combination after completion of Part 1 and Part 2 in 7 additional participants. Part 4, An additional 65 participants t(11;14) positive will receive varying doses of the VenKd combination or carfilzomib and dexamethasone
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Carfilzomib
FDA approved
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 17 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 17 months for reporting.

Closest Location

University of Utah /ID# 151397 - Salt Lake City, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2.
Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
Received prior treatment with at least 1 prior line of therapy for MM.
Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can multiple myeloma be cured?

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Treatment with R-CHOP-R does not confer increased survival in patients with relapsed or refractory MM. Patients with refractory MM are not candidates for treatment with R-CHOP-R, and the increased toxicity of R-CHOP-R is not justified in these patients. Findings from a recent study suggest that treatment of RR MM with R-CHOP-R yields only delayed progress.

Unverified Answer

What are the signs of multiple myeloma?

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Multiple myeloma may remain dormant for years but may develop into monoclonal gammopathy over time. The presence of a clonal plasma cell proliferation within the bone marrow is the prerequisite for diagnosis of the disease. Some patients with multiple myeloma have no symptoms and may be diagnosed only during routine blood testing. Symptoms of multiple myeloma may not occur until they have progressed to an advanced stage and are symptomatic of a plasma cell type disorder.

Unverified Answer

What is multiple myeloma?

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Multiple myeloma is a type of cancer that forms in the bone marrow and forms a tumor mass filled with cells that can grow and enlarge in a body's tissues. Multiple myeloma is a disease that can occur in any age group, but it is most often diagnosed in people over the age of 65. Multiple myeloma has high cure rates if properly treated. The five-year survival rates for people with multiple myeloma are 80% to 90%. Multiple myeloma is an incurable disease after conventional treatment with chemotherapy or radiation therapy.

Unverified Answer

How many people get multiple myeloma a year in the United States?

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around 60,000 people in the US have newly diagnosed [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in 2017. The prevalence is 2.6/100 000 for men and 1.3/100 000 for women, respectively. There is a good correlation between age and myeloma prevalence. The five most frequently diagnosed and diagnosed sub-classes of disease in the United States are myeloma, lymphoma, breast/ovariary cancer, lung/bronchus cancer and leukemias. The lifetime risk is 1/600 for a healthy person. The cumulative lifetime risk of developing multiple myeloma in a population the size of the United States is approximately 1 in 2 000.

Unverified Answer

What are common treatments for multiple myeloma?

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Treatment of myeloma, like treatment of prostate cancer, is highly dependent on the specific case. Common treatments include chemotherapy, radiotherapy and/or transplantation. The combination of these agents is common, particularly with transplantation, and the decision to add a second agents is not always based solely on the disease stage. New therapies targeting the myeloma cell and bone matrix or agents that augment conventional therapy in patients with advanced or metastatic disease, are currently undergoing clinical and laboratory studies. Because the disease remains incurable, treatment should be individualized for as many reasons as are feasible and the patient's needs.

Unverified Answer

What causes multiple myeloma?

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Multiple myeloma is not caused by an excessive production of free light chains. Rather, multiple myeloma occurs because of the accumulation of plasma cells with genetic changes in the DNA which predispose these cells to produce and release proteins that cause B-cell dysfunction. summary: Results from a recent paper found no significant association between multiple myeloma and a number of potential risk factors.

Unverified Answer

Has venetoclax proven to be more effective than a placebo?

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Results from a recent paper suggests that venetoclax is effective in inducing tumor debulking and delaying disease progression in MM patients. Venetoclax is a very effective inhibitor of proliferation and induction of cell apoptosis, both of which are essential for the cytotoxic or cytostatic effect on MM. There were no apparent statistical significance differences with respect to overall or progression-free survival between venetoclax and the placebo arm.

Unverified Answer

Is venetoclax safe for people?

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This is the first clinical study of venetoclax in people with newly diagnosed MM. Our safety and tolerability data support evaluating the drug in people with newly diagnosed MM, but not in people with advanced MM. Clin Cancer Res; 1-11. ©2016 AACR.

Unverified Answer

Is venetoclax typically used in combination with any other treatments?

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In a recent study, findings suggest that, among all MM patients receiving treatment with venetoclax, about half did not receive any other treatment. In a recent study, findings suggest that a randomized, placebo-controlled trial of venetoclax-containing combinations in addition to chemotherapy is warranted.

Unverified Answer

What is the latest research for multiple myeloma?

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With a new treatment, survival duration is increasing, but this research will help patients choose the treatment that will be best for them. Because the overall five year survival rate from a new treatment to that of the standard treatment was only 37%, the authors urge scientists to continue improving the outcome from existing treatments and to search for new therapies to cure multiple myeloma.

Unverified Answer

What are the latest developments in venetoclax for therapeutic use?

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Venetoclax has a well demonstrated role in the treatment of patients with relapsed diffuse large B-cell lymphoma. Clinical trials have shown it to be a very effective drug. It is a drug that is approved by the FDA and EMA for many types of cancer. What has been previously highlighted is the issue of resistance and its potential to develop between patients on venetoclax monotherapy. The current clinical trials will continue to determine the value of this drug in a clinical setting while considering that chemotherapy resistance is a significant issue.

Unverified Answer

What are the common side effects of venetoclax?

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We report a number of common clinical side events associated with venetoclax, including a dose-dependent neutropenia, anaemia, thrombocytopaenia, upper GI disturbances, skin-related symptoms, headache, fatigue and nausea (all with an incidence of ≥10%). Additional side effects were rare in this study, including pulmonary embolism, fever, diarrhoea, dyspnea, hypoxaemia and pneumonitis. Although the incidence of some of these side effects appears lower in the current data compared to that in previous reports and clinical trial databases, clinicians handling venetoclax should be prepared to manage these rare but potentially life-threatening adverse events.

Unverified Answer
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