Ixazomib for Multiple Myeloma

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Multiple Myeloma+2 More
Ixazomib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Multiple Myeloma

Study Summary

This study is evaluating a new drug called "ixazomib" as a possible treatment for Smoldering Multiple Myeloma.

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Eligible Conditions

  • Multiple Myeloma
  • Smoldering Multiple Myeloma
  • Neoplasms, Plasma Cell

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Ixazomib will improve 1 primary outcome and 5 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died, or up to 60 months post initiation of therapy.

2 years
Objective Response Rate
Proportion Of High Risk SMM Patients Who Are Progression Free 2 Years After Receiving IRD Combination Therapy
Month 60
Time To Progression
Month 60
Overall Survival
Month 60
Progression Free Survival
Month 60
Duration of Response

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

2 Treatment Groups

Control
Ixazomib

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ixazomib 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.

IxazomibCycles 1-9 Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle Lenalidomide is administered orally on days 1-21 on a 28 days cycle Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle Cycle 10-24 Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle Lenalidomide is administered orally on days 1-21 on a 28 days cycle Supportive measures consistent with optimal patient care may be given throughout the study
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Dexamethasone
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
I. G.
Irene Ghobrial, MD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who are 18 years or older. show original
This text is saying that if someone has a serum M protein level of 3.0g/dL or higher, it means they have an IgA, IgG, IgM, or IgD antibody. show original
is observed in majority of patients with common variable immunodeficiency show original
The level of M protein is gradually increasing, evolving into a type of SMM. show original
, with no change in other serum proteins If the level of a specific serum protein increases by 10% or more on two separate occasions within a six-month period, this is considered a sign of monoclonal protein show original
IgA SMM
The serum free light chain ratio is ≥8 (but less than 100). show original
----Free Light Chain Smoldering Myeloma patients as defined in section 2.4 are not excluded
of all cells Bone marrow clonal plasma cells are present in 50-60% of all cells. show original
Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes

Patient Q&A Section

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

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

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MM incidence has risen significantly in the past 15 years in the U.S., [even in individuals with normal serum protein levels] which was also documented in European reports [1], [2]. MM incidence also varies geographically, in a manner similar to that of age and sex, [2,3]. The increased incidence of MM, especially in elderly individuals, is likely not to occur because this is not a disease of middle age. It is postulated that MM is attributable to an environmental trigger that has been identified and that it may be a disease of people who have a genetically predisposed immunodeficiency of the immune system.

Unverified Answer

What are the signs of multiple myeloma?

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M-symptoms and abnormalities of the blood and urine in cancer patients should prompt further testing of interest. Nail lesions, thrombocytosis, protein in the urine, low serum albumin and low platelet count would

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What causes multiple myeloma?

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There is limited evidence that cigarette smoking or exposure to occupational irritants is associated with a modest increased risk of developing multiple myeloma after controlling for environmental exposures, including diet and genetic factors. Future studies are needed to further elucidate the mechanisms by which multiple myeloma develops.

Unverified Answer

What is multiple myeloma?

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The most common type of plasma cell dyscrasia is multiple myeloma but it is a heterogeneous disease with several subtypes. It is a neoplasm of plasma cells but that's not always the case; in addition to multiple myeloma, many other disorders have their origins in plasma cells. Multiple myeloma is characterized by the proliferation of plasma cells that have one of several genetic abnormalities, generally t(14;18).

Unverified Answer

What are common treatments for multiple myeloma?

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Multiple myeloma has historically been treated with high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. However, the combination of autologous bone marrow transplantation and high-dose chemotherapy has been shown to result in a prolonged survival time. Therefore, autotransplantation has become the standard method of chemotherapy for multiple myeloma. Although patients with newly diagnosed early-stage multiple myeloma may be eligible for autografting and maintenance chemotherapy, there are no well-defined guidelines for multiple myeloma patients who are candidates for autotransplants. Clinicians must balance the benefits and risks of salvage procedures against a patient's physical abilities to complete the procedure.

Unverified Answer

Can multiple myeloma be cured?

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The 5 year and 10 year overall survival were 74% and 62% for patients with MM, respectively. There were no significant differences found with respect to age, gender, type or number of M-MM subclones, RISS, and Bortezomib dosage, and treatment duration.

Unverified Answer

What are the common side effects of ixazomib?

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Ixazomib did not induce the common side effects of lenalidomide. For some side effects, lenalidomide produced higher incidence of side effects than ixazomib. The rate of nausea and vomiting in ixazomib treatment were similar to that in lenalidomide treatment. Ixazomib did not alter or delay the resolution of diarrhea and constipation experienced with lenalidomide treatment. The most common grade>or=2 side effects of ixazomib therapy were fatigue, depression, vomiting, diarrhea, asthenia, headache, and dizziness.

Unverified Answer

Has ixazomib proven to be more effective than a placebo?

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Ixazomib is very effective with a manageable and tolerable side effect profile, and it is well-tolerated in both patients with newly diagnosed multiple myeloma and those in remission.

Unverified Answer

What does ixazomib usually treat?

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Ixazomib seems to work in MM that has relapsed after more than one lines of therapy. More investigations, such as a long term effectiveness study, are needed to better understand which treatments work for what patients.

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What is the average age someone gets multiple myeloma?

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Most (59%) of the respondents in this survey first developed multiple myeloma before the age of 40 years. People most often develop multiple myeloma in the fifth decade of life (31% of the respondents), while almost half first developed multiple myeloma after the age of 70 years.

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Have there been other clinical trials involving ixazomib?

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There was one ongoing clinical trial for myeloma at the time of writing. The drug failed three times in its last two cycles. As of August 2019, the Drug Information Center at the National Cancer Institute lists a number of ongoing clinical trials involving ixzomib on its webpage. The American Society of Hematology recommends ixzomib for patients with newly diagnosed, relapsed or refractory multiple myeloma.

Unverified Answer

What is the survival rate for multiple myeloma?

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On average, survival time (also referred to as progression-free survival or FPS) for patients with multiple myeloma after treatment with an [Interferon alpha (IFNα) or Bortezomib (BZ)(Velcade)(Zorznain, Vypros, Zelboraf, Tecerdapim)] is approximately 5-8 months. Median progression free time after [IFNα] is approximately 4 months, whereas [BZ] is approximately 12 months. One-year survival has not changed significantly since [BZ] treatment.

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