Ixazomib + Dexamethasone for Smoldering Multiple Myeloma

Recruiting at 7 trial locations

Overseen by Sham Mailankody, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the combination of two drugs, ixazomib and dexamethasone, in patients with early-stage multiple myeloma. The goal is to see if these drugs can prevent or delay the disease from getting worse. Ixazomib works by stopping cancer cells from breaking down proteins, and dexamethasone helps reduce inflammation and kill cancer cells.

Research Team

Sham Mailankody, MBBS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with Smoldering Multiple Myeloma who haven't had prior treatments with proteasome inhibitors, have no severe diseases or infections like HIV or hepatitis, and can perform daily activities (ECOG 0-2). They must not be pregnant, breastfeeding, or on certain drugs that affect the trial medications. Participants need normal organ function and agree to use effective contraception.

Inclusion Criteria

My kidneys work well enough (creatinine clearance > 30 mL/min).

You do not have anemia caused by a specific disorder, which means your hemoglobin level is above 10 g/dl or not more than 2 g/dL below the lower limit of normal.

You have more than one specific spot on your MRI scan.

Exclusion Criteria

Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent

I have been diagnosed with multiple myeloma.

I have been treated for smoldering multiple myeloma with a proteasome inhibitor.

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• Ixazomib (MLN9708) (Proteasome Inhibitor)

Trial Overview The study is testing the effects of ixazomib combined with dexamethasone on patients with high-risk smoldering multiple myeloma. It aims to understand how well these drugs work together in controlling this condition without causing significant harm.

Participant Groups

Group I: Ixazomib (MLN9708) and Dexamethasone Experimental Treatment 2 Interventions

Patients with high risk SMM will be enrolled on the pilot study and treated with 2 drug combination (Cycles 1-12 Ixazomib at 4 mg weekly on days 1, 8 and 15, and dexamethasone on days 1, 8, 15 and 22 of 28 day cycle); the dexamethasone dose will be 40 mg/week the first 4 cycles, thereafter 20 mg/week.

Dexamethasone is already approved in Canada, Japan for the following indications:

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Millennium Pharmaceuticals, Inc.

Industry Sponsor

Trials

406

Recruited

46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand