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CAR T-cell Therapy

Combination Therapies for Multiple Myeloma (aMMbition Trial)

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with documented new diagnosis of multiple myeloma (MM) according to international myeloma working group (IMWG) diagnostic criteria

Participants must have standard-risk MM (stage I and II) based on revised International Staging System (R-ISS)

Must not have

Presence of high-risk disease features: (a) Cytogenetic high risk lesions by MM fluorescence in situ hybridization (FISH) including deletion 17p (del[17p])/, t(4;14), t(14;16), amplification 1q (amp[1q21]) (>= 4 copies); (b) Presence of 1 or more extramedullary plasmacytomas

Seropositive for human immunodeficiency virus (HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see how well the treatment is working by evaluating the rate of response and potential cure after 5 years. They will look at whether the treatment leads to minimal residual disease negativity, complete

Who is the study for?

This trial is for individuals with newly diagnosed standard-risk multiple myeloma. Participants will initially receive a combination of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone before being tested with different sequences of cancer treatments including Cilta-cel, Talquetamab in combination with Daratumumab and Teclistamab in combination with Daratumumab.

What is being tested?

The study tests the effectiveness of treatment sequences on achieving sustained minimal residual disease negativity (no detectable cancer cells) combined with complete response to therapy at 5 years post-treatment initiation. It also measures how long patients live without their disease worsening (progression-free survival).

What are the potential side effects?

Potential side effects may include reactions related to immune system activation against cancer cells or normal tissue, blood disorders, infections due to lowered immunity from chemotherapy drugs like Cyclophosphamide and Fludarabine, bone marrow suppression by Lenalidomide or Dexamethasone causing fatigue or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with multiple myeloma.

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My multiple myeloma is classified as stage I or II.

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I am considered fit or intermediate-fit for treatment based on a health assessment.

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My blood or urine tests show signs of multiple myeloma.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has high-risk features according to specific genetic tests.

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I am HIV positive.

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I do not have ongoing blood disorders or cancer, other than multiple myeloma, that needs treatment.

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I have or had brain or spinal cord involvement by my cancer.

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I have not had a stroke or seizure in the last 6 months.

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I have a specific blood cancer or related syndrome with significant symptoms.

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I have moderate to severe nerve pain or damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS Rate at 5-Year

Progression Free Survival (PFS) Rate at 3-Year

Rate of Response with Curative Potential

Secondary study objectives

CR or Better Rate

Change from baseline in Health-related quality of life (HRQoL) (symptoms and functioning) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 item instrument (EORTC-QLQ-C30)

Duration of CR or Better Response

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D ConsolidationExperimental Treatment9 Interventions

Participants will undergo apheresis followed by 4 cycles of DVRd induction and Cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release and completion of induction, participants will begin consolidation with a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days) with infusion of cilta-cel 5 to 7 days after the start of the conditioning regimen. Following cilta-cel infusion, alternating cycles of Tal-D (Cycle 1, 3, 5, and 7) and Tec-D (Cycle 2, 4, 6, and 8) will be started, no earlier than Day 84 and no later than Day 168 post cilta-cel infusion. Each cycle of Tal-D and Tec-D is 84 days which includes an extended treatment-free interval.

Group II: Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-celExperimental Treatment8 Interventions

Participants will undergo apheresis followed by 4 cycles of DVRd induction (each cycle is of 28 days) and cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release, and completion of induction, participants will begin consolidation with 4 cycles of Tal-D (each cycle is of 28 days), followed by a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days); cilta-cel will be administered 5 to 7 days after the start of the conditioning regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 3

~1410

Daratumumab

2014

Completed Phase 3

~2380