Quadruple Therapy + Stem Cell Transplant for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+21 other locations

Gunjan L. Shah, MD - MSK Bone Marrow ...

Overseen byGunjan Shah, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to test any good and bad effects of giving a combination of study drugs before and after autologous stem cell transplant.

Eligibility Criteria

This trial is for adults aged 18-75 with multiple myeloma that has worsened after 1 to 3 treatments. They must have enough healthy stem cells saved, good kidney function, and no severe heart or liver issues. Women who can get pregnant and men must use birth control. People with HIV, uncontrolled illnesses, recent major surgery, CNS myeloma involvement, significant neuropathy or allergic reactions to the drugs are excluded.

Inclusion Criteria

Your disease can be measured according to specific guidelines from the International Myeloma Working Group.

My heart pumps well, with an ejection fraction over 40%.

I've had one treatment cycle for my disease within the last 60 days and waited 4 weeks since the last dose.

+20 more

Exclusion Criteria

My blood test shows more than 20% plasma cells.

I have been diagnosed with POEMS syndrome.

I have not had major surgery in the last 3 weeks.

+17 more

Participant Groups

The study tests a combination of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab given before and after an autologous stem cell transplant in patients with relapsed/refractory multiple myeloma. The goal is to see the effects of this regimen on the disease's progression.

1Treatment groups

Experimental Treatment

Group I: Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab & HCTExperimental Treatment5 Interventions

After receiving four 28-day cycles of Dara-CRd, eligible patients will then undergo HCT with high dose melphalan conditioning. Sixty to ninety days after HCT, patients will receive another 4 cycles of Dara-CRd.

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

🇺🇸 Approved in United States as Kyprolis for: