Apply to Trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Quadruple Drug Therapy for Multiple Myeloma

Recruiting at 2 trial locations

Overseen ByElizabeth O'Donnell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Strong CYP inhibitors, inducers

Disqualifiers: COPD, HIV, Hepatitis B/C, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This research study is testing the efficacy of an experimental drug combination for people with newly diagnosed multiple myeloma that are eligible for a stem cell transplant. The names of the study drugs involved in this study are: * Carfilzomib * Isatuximab * Lenalidomide * Dexamethasone

Research Team

Elizabeth O'Donnell, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with newly diagnosed multiple myeloma who meet specific health criteria and are eligible for a stem cell transplant. They must have measurable disease, be in relatively good physical condition (ECOG score of 0-2), and agree to use effective contraception. People can't join if they've had certain treatments for multiple myeloma before, active infections like HIV or hepatitis B/C, recent major surgery or radiation therapy, other medical conditions that could affect the study, or if they're pregnant.

Inclusion Criteria

I have multiple myeloma with symptoms or measurable disease.

I am using reliable birth control methods.

Each subject (or their legally acceptable representative) must sign an informed consent form (ICF)

See 4 more

Exclusion Criteria

You have a history of HIV, hepatitis B, or hepatitis C.

I do not have a stomach or bowel condition that affects how I absorb pills.

I have had treatment for multiple myeloma, except for emergency steroids.

See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive 4 cycles of induction therapy with Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone. Stem cell collection occurs after 4 cycles, with potential for autologous stem cell transplant.

16 weeks

Weekly visits for drug administration

Maintenance

Participants receive maintenance therapy based on risk stratification for up to two years or until disease progression or unacceptable toxicity.

24 months

Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

Carfilzomib
Dexamethasone
Isatuximab
Lenalidomide

Trial OverviewThe trial is testing a new combination of drugs: Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone in people with multiple myeloma who can undergo a stem cell transplant. The goal is to see how well this experimental drug mix works against this type of cancer.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Maintenance-High RiskExperimental Treatment4 Interventions

Only patients that have achieved a partial response (PR) or better after induction therapy with or without stem cell transplant will continue on to maintenance therapy. The treatment participants will receive for maintenance will be based on the biological features (or cytogenetics) of participants myeloma and categorized into two groups: Standard-risk and High Risk. High Risk: subjects with high risk cytogenetics (deletion (del 17, translocation (t)(4:14), t(14;16), t(14;20), 1q duplications) will receive the following study treatment for up to two years (24 28-day cycles) until progressive disease (PD) or unacceptable toxicity: Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1

Group II: Maintenance- Standard RiskExperimental Treatment1 Intervention

Only patients that have achieved a partial response (PR) or better after induction therapy with or without stem cell transplant will continue on to maintenance therapy. The treatment participants will receive for maintenance will be based on the biological features (or cytogenetics) of participants myeloma and categorized into two groups: Standard-risk and High Risk. Standard Risk: subjects without high risk cytogenetics (deletion (del 17, translocation (t)(4:14), t(14;16), t(14;20), 1q duplications) will receive the following study treatment for up to two years (24 28-day cycles) until progressive disease (PD) or unacceptable toxicity: - Lenalidomide 10 mg orally (PO) Day 1-21

Group III: InductionExperimental Treatment4 Interventions

All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications: