Daratumumab + T Cell Redirecting Antibodies for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.

Eligibility Criteria

This trial is for adults with multiple myeloma who've had at least three prior treatments, including specific drugs like proteasome inhibitors and immunomodulatory drugs. They should be relatively healthy (ECOG grade of 0 or 1) and not pregnant if female. People can't join if they've recently used certain anti-CD38 therapies, received live vaccines, or have active hepatitis or central nervous system involvement by the cancer.

Inclusion Criteria

My condition did not improve after treatments including a PI and an IMiD.

You must have a specific amount of disease that can be measured according to certain rules.

My multiple myeloma diagnosis follows international guidelines.

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Exclusion Criteria

I haven't had CD38 therapy in the last 3 months or stopped it due to side effects.

I haven't had a live vaccine in the last 4 weeks or it was approved by the study sponsor.

You have a positive test for hepatitis B or an active hepatitis C infection.

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Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)
Pomalidomide (Immunomodulatory Agents)
Talquetamab (Bispecific Antibodies)
Teclistamab (Bispecific Antibodies)

Trial OverviewThe study is testing combinations of Daratumumab with Talquetamab or Teclistamab, with some groups also getting Pomalidomide. The goal is to find safe doses for these combos and see how well they work together in treating multiple myeloma.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment4 Interventions

Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1.

Group II: Part 1: Dose EscalationExperimental Treatment4 Interventions

Participants will be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide.

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