Daratumumab for Smoldering Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+5 other locations

Irene Ghobrial, MD - Dana-Farber Cancer ...

Overseen byIrene Ghobrial, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM). The drug involved in this study is: -Daratumumab

Eligibility Criteria

Adults with high-risk MGUS or low-risk Smoldering Multiple Myeloma who haven't had treatment for these conditions can join. They must be in decent health, have certain blood and organ function levels, not be pregnant, and able to consent. Excluded are those with recent cancers (with exceptions), severe illnesses, major surgery within the last month, or on other clinical trials.

Inclusion Criteria

I am 18 years old or older.

My condition is either high-risk MGUS or low-risk smoldering myeloma.

I am a woman who has been postmenopausal for at least a year or am surgically sterile.

See 6 more

Exclusion Criteria

Serious medical or psychiatric illness likely to interfere with participation in this clinical study

I have COPD with less than half the normal lung function.

You have a known active viral infection with HIV, HBV, or HCV.

See 13 more

Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing Daratumumab as a potential treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Multiple Myeloma (SMM). It's a Phase II study which means they're looking at how effective this drug is and gathering more information about its safety.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: DaratumumabExperimental Treatment1 Intervention

Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20

Daratumumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Darzalex for:

Relapsed and refractory multiple myeloma
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

🇺🇸 Approved in United States as Darzalex for:

Multiple myeloma in patients who have received at least three prior therapies
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone