ixazomib for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lakeland Hospital Niles, Niles, MI
Multiple Myeloma+2 More
ixazomib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether pomalidomide and ixazomib are safe and effective when given together with dexamethasone.

See full description

Eligible Conditions

  • Multiple Myeloma
  • Multiple Myeloma in Relapse

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether ixazomib will improve 2 primary outcomes and 12 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 4 weeks post study treatment.

Up to 28 days
Maximum Tolerated Dose (MTD) of pomalidomide and ixazomib, determined according to incidence of dose limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Up to 3 years
Clinical benefit rate (CBR), defined as minimal response (MR) and better according to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
Disease control rate (DCR), defined as stable disease (SD) and better according to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
Duration of response (DOR), calculated for all patients achieving an objective response, partial response (PR) or better (Phase II)
Overall response rate (ORR), defined as partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
Overall survival (OS) (Phase II)
Response rates (overall response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR) for all patients on the pomalidomide/dexamethasone arm at the time of cross-over to pomalidomide/dexamethasone/ixazomib (Phase II)
Year 3
Progression free survival (PFS) (Phase II)
Time to next treatment (TNT) (Phase II)
Year 3
Progression free survival (PFS) for all patients on the pomalidomide/dexamethasone arm at the time of cross-over to pomalidomide/dexamethasone/ixazomib (Phase II)
Week 4
Incidence and type of dose limiting toxicities (DLTs), serious adverse events, and adverse events, graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Week 4
Incidence of dose reductions/delays (Phase I)
Incidence, type and severity of adverse events, graded according to National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) version 4.0 (Phase II)
baseline
Baseline level of perceived fatigue and QOL, assessed using the Registration Fatigue/Uniscale Assessment form (Phase II)

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Myeloma

Trial Design

2 Treatment Groups

Arm II (pomalidomide, dexamethasone, ixazomib)
1 of 2
Arm I (pomalidomide, dexamethasone)
1 of 2
Experimental Treatment

This trial requires 117 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ixazomib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm II (pomalidomide, dexamethasone, ixazomib)Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm I (pomalidomide, dexamethasone)Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Dexamethasone
FDA approved
Ixazomib
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Lakeland Hospital Niles - Niles, MI

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 one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
(FLCR) A person has multiple myeloma if they have a serum M-protein level of 1.0 g/dL or more, a urine M-protein level of 200 mg/24 hours or more, and an abnormal serum free light chain ratio. show original
A patient who has received induction therapy with lenalidomide, bortezomib and dexamethasone and has achieved a PR or better but then progresses on continued lenalidomide or lenalidomide-dexamethasone is eligible provided the progression occurs at least 60 days after discontinuation of the bortezomib show original
Allogeneic stem cell transplantation is allowed provided the patient is >= 1 year from transplant at time of registration, is not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft versus host disease, and no evidence of active infection
Myeloma patients who have a baseline marrow burden of at least 30% are likely to respond better to treatment. show original
; 3) disease progression on lenalidomide-based therapy, but later sensitivity to lenalidomide as evidenced by tumor regression after discontinuation of lenalidomide Lenalidomide-refractory disease is defined as disease progression on or within 60 days of the last dose of a lenalidomide-based treatment show original
A disease that has not been treated with the drug pomalidomide. show original
The patient has been diagnosed with multiple myeloma, a condition that has previously responded to treatment but has since progressed. show original
There is evidence to suggest that lenalidomide may be effective as part of first line therapy for people with lenalidomide-refractory disease. show original
1 prior line of systemic therapy for multiple myeloma, where a line of therapy for myeloma is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy); a new line of therapy begins when a planned therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, disease relapse or treatment-related toxicity (e.g. a patient is progressing in the face of lenalidomide maintenance therapy and has bortezomib and dexamethasone added into their regimen); a new line of therapy also begins when a planned treatment-free interval is interrupted by the need to start treatment due to disease relapse/progression (e.g. a patient with relapsed myeloma achieves a partial response after a planned 8 cycles of cyclophosphamide, bortezomib and dexamethasone, enjoys an 8-month period off therapy but then experiences disease progression requiring re-initiation of therapy)
participants may not have received radiation therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational agent within 14 days prior to registration. show original

Patient Q&A Section

What are the chances of developing multiple myeloma?

"The overall risk of developing multiple myeloma depends on the risk of developing one individual cancer type independently. The probability of developing multiple myeloma is greater when a person develops one of the solid tumor cancers. Those with solid tumors have an increased risk of developing multiple myeloma over the following 15 years, compared with people with only non-solid tumors." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ixazomib?

"There is no evidence that ixazomib, as currently used, has major drug interactions. However, there are no studies of ixazomib as a monotherapy, except for those in post-hx rels. There is little data available regarding the safety and efficacy of ixazomib in combination, but a recent Phase III study on relapsed and refractory multiple myeloma found a higher than expected response rate in patients with refractory to bortezomib-based regimens with a minimum PFS of 7.5 months, which is in the same range as those reported with ixazomib." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for multiple myeloma?

"There are important prognostic factors for prognosis of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) patients. Survival rate appears to correlate with disease stage and occurrence of extramedullary myeloma. Survival rates can be predicted with the use of multivariate Cox model including parameters which can be obtained before initiation of treatment or before the occurrence of myeloma." - Anonymous Online Contributor

Unverified Answer

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

"Almost 9 in 10 MM cases will be treated with one of the various agents or combinations of agents currently available and use in MM. In addition, MM represents about a quarter of all hematologic malignancies (excluding leukemia) seen by oncology providers in the U.S. A single institution in New Haven County, Connecticut, treated 9,832 MM patients in a 2-year period between 1988 and 1990 and documented that at this facility and in a large number of other hospitals, 8,050 MM patients were treated between 1980 and 1983. Based on these reported data, multiple myeloma is expected to be responsible for about 4.8% of all hematological malignancies in the U.S." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Effective treatment with corticosteroids, immunotherapy, or, especially, combination therapy, is associated with a 50% or higher chance of five-year overall survival in patients with multiple myeloma. A prospective, multicenter study with standardized follow-up is needed to establish cure of multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"There is some evidence of both genetic and environmental involvement in multiple myeloma, but these explanations do not fully account for the observed associations. There is further evidence for a role of viruses in the carcinogenesis of multiple myeloma and for viral infection in the development of multiple myeloma, with links possibly between multiple myeloma and human T-lymphotropic virus 1." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Most patients with MM experience loss of appetite and weight loss and they often have fatigue. Patients with multiple myeloma may have low self-esteem, which is evident when they discuss their symptoms because they may be viewed as a debilitating disease by their friends or family members." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Patients diagnosed with MM may have difficulty navigating the health care system, and experience high levels of distress and quality of life impairment. Findings from a recent study suggest early initiation of adjunctive services for treatment of cancer symptom distress to maintain psychological, physical, social, and spiritual well being." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"Due to variations in health insurance systems, medical coverage, and treatment in each country, this list is only indicative, and not exhaustive, of the most common treatments for common MM variants. While some treatments are less common in some places, some treatments are more often administered in the developed world, where they are often more effective. In all likelihood, the vast majority of patients with MM received standard therapies before the discovery and development of newer treatments. These treatments often are effective at arresting or slowing progression of disease and improving symptoms, but they do not cure multiple myeloma. While treatments are improving, they are still necessary because MM is a rapidly progressing disease, and most patients relapse within 5 years of treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple myeloma?

"In this large and nationwide sample, patients treated between 1990s and early 2000s accounted for about 50% of all MM patients. Male and older patients were associated with shorter survival, as were young patient without a partner and with multiple myelomatous syndromes." - Anonymous Online Contributor

Unverified Answer

Has ixazomib proven to be more effective than a placebo?

"Ixazomib proved to be more effective than a placebo for the treatment of relapsed and refractory patients with multiple myeloma. In a recent study, findings suggest ixazomib could be a standard treatment option for this indication." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of multiple myeloma?

"The overall results illustrate the complexity of both genetic factors and environmental factors in multiple myeloma. The clinical manifestations of multiple myeloma are the results of a complex interplay between somatic mutation, environmental risk factors, and the immunologic response to neoplastic cells." - Anonymous Online Contributor

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