Daratumumab-based Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByMatthew Pianko, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.

Eligibility Criteria

This trial is for adults with newly diagnosed Multiple Myeloma who have measurable disease and can tolerate treatments, including high-dose chemotherapy and stem cell transplant if needed. Participants must not have had more than one cycle of myeloma therapy before joining, be free from certain blood/liver diseases, HIV, Hepatitis B/C, other active cancers in the last five years, or significant heart or lung conditions.

Inclusion Criteria

I have a bone marrow or tissue sample available for testing.

I am registered and comply with the REMS program for lenalidomide.

I am a man willing to follow specific rules about contraception or abstinence.

+7 more

Exclusion Criteria

I am allergic or cannot take certain medications required for this study.

I am not pregnant or breastfeeding.

Participation in other clinical trials within 30 days of the start of this trial and throughout the duration of this trial

+13 more

Participant Groups

The study tests a combination of drugs (daratumumab + lenalidomide + dexamethasone) as initial treatment. If minimal residual disease is detected afterward, an additional drug (bortezomib) is added. The approach adapts to each patient's response to maximize chances of eliminating all signs of cancer at a microscopic level.

1Treatment groups

Experimental Treatment

Group I: Dara-Rd followed by Dara-RVdExperimental Treatment4 Interventions

* Induction regimen with Daratumumab, Lenalidomide and Dexamethasone (Dara-Rd) in all study subjects, weeks 1-24 * Consolidation regimen with Daratumumab, Lenalidomide, Bortezomib and Dexamethasone (Dara-RVd) in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance

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