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Monoclonal Antibodies

Daratumumab + T Cell Redirecting Antibodies for Multiple Myeloma

Phase 1

Waitlist Available

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

Must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) in any order during the treatment or have disease that is double refractory to a PI and an IMiD

Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria

Must not have

Treatment in the prior 3 months with an anti-cluster of differentiation 38 (CD38) therapy or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy

Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to cycle 7 day 1 (each cycle of 28-days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different doses of two drugs to see which are safe and effective in treating myeloma.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include reactions at the injection site, immune system complications that may affect various organs, fatigue, nausea, blood count changes which could increase infection risk. Each person's reaction to treatment can vary.

Eligibility Criteria

Inclusion Criteria

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

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

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My multiple myeloma diagnosis follows international guidelines.

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

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My multiple myeloma has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to cycle 7 day 1 (each cycle of 28-days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to cycle 7 day 1 (each cycle of 28-days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to cycle 7 day 1 (each cycle of 28-days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Part 1: Number of Participants With Dose Limiting Toxicity by Severity

Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

+1 more

Secondary study objectives

Biomarker Assessment of Daratumumab

Biomarker Assessment of Talquetamab

Biomarker Assessment of Teclistamab

+10 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

44%

Thrombocytopenia

38%

Peripheral sensory neuropathy

38%

Peripheral Sensory Neuropathy

32%

Anaemia

24%

Fatigue

22%

Diarrhoea

17%

Upper respiratory tract infection

17%

Upper Respiratory Tract Infection

16%

Constipation

15%

Insomnia

15%

Asthenia

13%

Cough

11%

Nausea

11%

Neuralgia

11%

Pyrexia

11%

Dizziness

10%

Back pain

10%

Back Pain

10%

Pneumonia

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Arthralgia

Headache

Paraesthesia

Bronchitis

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Dyspepsia

Hypocalcaemia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Hypophosphataemia

Rash

Abdominal Pain Upper

Conjunctivitis

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Muscle spasms

Aspartate aminotransferase increased

Urinary tract infection

Myalgia

Herpes zoster

Musculoskeletal chest pain

Herpes Zoster

Pulmonary Embolism

Weight Decreased

Pulmonary embolism

Myocardial infarction

Dehydration

Myocardial Infarction

Lower Respiratory Tract Infection

Abdominal Pain

Orthostatic Hypotension

General Physical Health Deterioration

General physical health deterioration

Hyponatraemia

Condition aggravated

Orthostatic hypotension

Lower respiratory tract infection

Syncope

Productive cough

Nasal congestion

Respiratory failure

Weight decreased

Chills

Gastroenteritis

Sepsis

Respiratory Failure

Condition Aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Bortezomib + Dexamethasone (Vd)

Daratumumab + Bortezomib and Dexamethasone (DVd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pomalidomide

2011

Completed Phase 2

~1020

Daratumumab

2014

Completed Phase 3

~2000