Quadruple Therapy for Multiple Myeloma (ASCENT Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen ByBrian Durie, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: International Myeloma Foundation

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.

Eligibility Criteria

This trial is for adults aged 18-80 with high-risk smoldering multiple myeloma that hasn't been treated. Participants must be willing to use birth control, not have heart failure or HIV, and can't be pregnant or nursing. They should not have other serious health issues or recent major surgery and must agree to follow the study's procedures.

Inclusion Criteria

My smoldering myeloma is high risk and untreated.

I can take daily aspirin for blood clot prevention.

I am between 18 and 80 years old.

Exclusion Criteria

I have heart problems that are not currently under control.

I have heart failure that affects my daily activities.

I have had radiation therapy for bone lesions or plasmacytomas.

I haven't had or been treated for another cancer within the last 2 years.

I am not pregnant, nursing, or if capable of childbearing, I agree to use contraception.

I have not had major surgery in the last 2 weeks.

I have severe nerve pain or damage in my hands or feet.

I have been diagnosed with a specific blood or bone marrow condition.

I am HIV positive.

Participant Groups

The study tests a combination of carfilzomib, lenalidomide, daratumumab, and dexamethasone in three phases over several cycles for treating high-risk smoldering multiple myeloma. Each phase has different durations but all aim to evaluate the effectiveness of this regimen.

1Treatment groups

Experimental Treatment

Group I: Arm AExperimental Treatment4 Interventions

Non-high dose treatment in 3 phases Induction 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Consolidation 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Maintenance 12 cycles: lenalidomide, daratumumab

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

🇺🇸 Approved in United States as Kyprolis for: