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Kinase Inhibitor

Dabrafenib + Trametinib for Multiple Myeloma

Phase 1

Recruiting

Led By Noopur S Raje, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is studying how well targeted therapy works in treating multiple myeloma.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma, who have certain levels of monoclonal proteins in their blood or urine and have tried at least two other treatments. They should be relatively active (able to care for themselves) and not bedridden.

What is being tested?

The study is testing the effectiveness of two targeted therapy drugs, Trametinib and Dabrafenib, as potential treatments for multiple myeloma. It aims to see how well these drugs work on their own or together in treating this condition.

What are the potential side effects?

Trametinib and Dabrafenib can cause side effects like fever, fatigue, skin rash, nausea, heart issues, high blood pressure, bleeding problems, eye problems, liver toxicity among others. The severity of side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response Rate

Secondary study objectives

Number of Participants with Severe Adverse Events

Side effects data

From 2021 Phase 3 trial • 552 Patients • NCT03551626

68%

Pyrexia

32%

Headache

30%

Blood creatine phosphokinase increased

27%

Diarrhoea

26%

Fatigue

26%

Chills

24%

Asthenia

23%

Nausea

21%

Arthralgia

21%

Rash

15%

Vomiting

15%

Myalgia

14%

Alanine aminotransferase increased

14%

Cough

13%

Lipase increased

13%

Aspartate aminotransferase increased

12%

Influenza like illness

12%

Oedema peripheral

Pain in extremity

Neutropenia

Abdominal pain

Constipation

Muscle spasms

Back pain

Blood alkaline phosphatase increased

Decreased appetite

Hypophosphataemia

Dyspnoea

Erythema

Hypertension

Amylase increased

Hyperglycaemia

Dry skin

Dizziness

Abdominal pain upper

Pain

Pruritus

Oropharyngeal pain

Ejection fraction decreased

Atrial fibrillation

Erysipelas

Cellulitis

Basal cell carcinoma

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Dabrafenib+Trametinib (On-treatment)

Dabrafenib+Trametinib (Post-treatment Follow-up)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: TrametinibExperimental Treatment1 Intervention

Determine if mutation in BRAF, KRAS, NRAS * KRAS or NRAS mutated * Treat cohort with Trametinib * Analysis * Treat cohort with Trametinib

Group II: Dabrafenib and TrametinibExperimental Treatment2 Interventions

Determine if mutation in BRAF, KRAS, NRAS * BRAF V600 mutated, BRAF/KRAS mutated, or BRAF/NRAS mutated, or BRAF non-V600 mutated * Treat cohort with Dabrafenib and Trametinib * Analysis * Treat cohort with Dabrafenib and Trametinib

Group III: DabrafenibExperimental Treatment1 Intervention

Determine if mutation in BRAF, KRAS, NRAS * BRAF V600 mutated * Treat cohort with Dabrafenib * Analysis * Treat cohort with Dabrafenib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

FDA approved

Dabrafenib

FDA approved

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