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Ixazomib Citrate, Lenalidomid...

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Brief Summary

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This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.

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Detailed Description

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This phase III randomized clinical trial was designed to assess the impact of the addition of ixazomib, lenalidomide, and dexamethasone to zoledronic acid the multiple myeloma progression rate at 5 years. A dynamic allocation procedure will be used to allocate an equal number of patients to each of the treatment arms. This procedure will balance the number of patients which falls into each of the following categories between the two treatment arms:

1. % of abnormal plasma cells in the bone marrow: 5-9%
2. age \< 60; % of abnormal plasma cells in the bone marrow \< 5%; and monoclonal protein/clonal light chains present in the blood or urine
3. age \< 60; % of abnormal plasma cells in the bone marrow \< 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease
4. age ≥ 60; % of abnormal plasma cells in the bone marrow \< 5%; and monoclonal protein/clonal light chains present in the blood or urine
5. age ≥ 60; % of abnormal plasma cells in the bone marrow \< 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease

The primary and secondary objectives are described below.

Primary objective

To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in increasing the time before progression to multiple myeloma.

Secondary objectives

1. To assess changes in minimal residual disease \[MRD\] by flow cytometry from study entry, at the completion of treatment, and at 1 year post registration.
2. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival.
3. To examine the pharmacodynamics effects of treatment on biochemical markers of bone formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and metabolism (OPG).

Follow-up requirements after documentation of progression to multiple myeloma includes a maximum of five years following registration.

Conditions

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Solitary Osseous Plasmacytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ixazomib + lenalidomide + dexamethasone + zoledronic acid

Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.

Group Type EXPERIMENTAL

ixazomib

Intervention Type DRUG

oral

lenalidomide

Intervention Type DRUG

oral

dexamethasone

Intervention Type DRUG

oral

zoledronic acid

Intervention Type DRUG

zoledronic acid

Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.

Group Type ACTIVE_COMPARATOR

zoledronic acid

Intervention Type DRUG

Interventions

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ixazomib

oral

Intervention Type DRUG

lenalidomide

oral

Intervention Type DRUG

dexamethasone

oral

Intervention Type DRUG

zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CD4+ cells are ≥ 250/mm\^3
* There is no history of AIDS defining conditions other than historically low CD4+ cell count.
* The following antiretroviral agents are not allowed: zidovudine, stavudine, protease inhibitors, combination pills with pharmacologic boosters.
* Recommended antiretroviral regimens to avoid PK interactions include strand integrase inhibitors with nucleoside and non-nucleoside reverse transcriptase inhibitors (for example, dolutegravir given with tenofovir and emtricitabine).
3. Patients with HBV infection are eligible provided they meet the other eligibility criteria and:

* There is no evidence of hepatic damage related to HBV infection.
* They have had consistently suppressed HBV viral load to undetectable levels by PCR for a minimum of 12 months.
4. Patients with HCV infection are eligible provided they meet the other eligibility criteria and:

* They have previously undergone curative therapy and have no evidence of active HCV infection.
* They have no evidence of liver damage owing to prior HCV infection.

Patients with active HCV infection should be referred for HCV treatment and standard radiotherapy for the plasmacytoma.
5. Patients cannot have:

* Known allergy to boron or excipients in the formulation.
* Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drugs including difficulty swallowing.
* Infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration.
* Diarrhea ≥ Grade 1, based on the NCI CTCAE categorization within 14 days of registration
* Life-threatening illness unrelated to cancer
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide, or similar drugs.
7. Peripheral Neuropathy: ≤ Grade 2 Peripheral Neuropathy
8. Adequate cardiac function, defined as:

1. No cardiac arrhythmias within 182 days of registration.
2. No congestive heart failure (CHF) within 182 days of registration.
3. No angina or myocardial infarction within 182 days of registration. In view of potential cardiac risk with lenalidomide, patients with stable angina will be excluded.
9. Concomitant Treatment: Patients cannot be on systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) within 14 days of registration.
10. QT c\< 470 milliseconds (msec) on a 12-lead ECG ≤ 28 days before registration
11. Dental evaluation within 35 days of registration: Complete dental exam; complete elimination of dental and periodontal pathology including crowns on teeth susceptible to fracture, extraction of non-restorable or periodontally uncorrectable teeth; creation of an oral environment that the patient can efficiently maintain in a high state of health; and oral hygiene instruction to maintain excellent oral health.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anuj Mahindra, MD

Role: STUDY_CHAIR

Scripps Health

Locations

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