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Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma

NCT01718743•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving ixazomib citrate together with lenalidomide may be effective in treating multiple myeloma.

Detailed Description

PRIMARY OBJECTIVES: I. Establish safety and efficacy of oral ixazomib citrate (MLN 9708) and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients. SECONDARY OBJECTIVES: I. Incidence of secondary primary malignancy. II. Evaluate the best response rate (stringent complete response \[sCR\]/near complete response \[nCR\]/very good partial response \[VGPR\]/partial response \[PR\]). III. Evaluate time to progression. IV. Evaluate time to next therapy. V. Evaluate the tolerability and toxicity. VI. Evaluate M. D. Anderson Symptom Inventory (MDASI)-myeloma symptom evaluation. OUTLINE: Beginning 60-180 days post-transplant, patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient must have undergone autologous stem cell transplantation, with melphalan as a preparative regimen, within 12 months of initiation of induction therapy for newly diagnosed myeloma
•Time to initiation of maintenance therapy; patients may start maintenance therapy as early as 60 days post-transplant and up to 180 days post-transplant; as long as they meet the following criteria:
•Platelet count \>= 100,000/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
•Neutrophil count \>= 1000/mm\^3; (no growth factors within 5 days prior to first dose of the study drug)
•Total bilirubin =\< 1.5 x upper limit of normal (ULN)
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
•Creatinine \< 2.5 mg/dL
•Recovered (i.e., =\< grade 1 toxicity) from the reversible effects of autologous stem cell transplant
•Patients whose primary therapy was changed due to suboptimal response of toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCT
•Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
+7 more criteria

Exclusion Criteria

•Patient has \>= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
•Major surgery within 14 days before the first dose of study drug
•Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708
•Known active central nervous system involvement
•Systemic treatment, within 14 days before study enrollment, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
•Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment
•Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
•Female subject who are lactating or have a positive serum pregnancy test during the screening period
•Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation or completion of treatment according to this protocol
•Corrected QT interval using Bazett's formula (QTcB) \> 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period; if a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
+5 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

December 3, 2012

Primary Completion Date

April 12, 2023

Completion Date

April 12, 2023

Last Updated

January 28, 2025

Enrollment

ACTUAL participants

Conditions

Hematopoietic Cell Transplantation RecipientPlasma Cell Myeloma

Interventions

Ixazomib Citrate

DRUG

Lenalidomide

DRUG

Questionnaire Administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant