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Proteasome Inhibitor

Combination Therapy for Multiple Myeloma

Phase 3

Recruiting

Led By Shaji K Kumar

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II

Patient must be able to undergo diagnostic bone marrow aspirate following preregistration

Must not have

Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception

Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a 4-drug combo vs. a 3-drug combo to see if the former is more effective in shrinking cancer or preventing its return.

Who is the study for?

Adults with newly diagnosed multiple myeloma who have completed initial treatment without progression, can undergo bone marrow tests, and have adequate organ function. They must not be pregnant or breastfeeding, agree to contraception if applicable, and have no severe allergies to trial drugs or their components.

What is being tested?

The EQUATE trial is comparing a four-drug combo (daratumumab, bortezomib, lenalidomide & dexamethasone) against a three-drug regimen (daratumumab, lenalidomide & dexamethasone) for effectiveness in shrinking or preventing the return of multiple myeloma.

What are the potential side effects?

Possible side effects include reactions at the injection site for daratumumab and hyaluronidase-fihj; nerve damage from bortezomib; blood clots from lenalidomide; and increased infection risk due to immune system suppression by dexamethasone.

Eligibility Criteria

Inclusion Criteria

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

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My multiple myeloma is considered standard risk, stage I or II.

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I can have a bone marrow test after signing up.

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My institution has the Clonality test results from Adaptive Biotechnologies.

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My hepatitis B virus load is undetectable with treatment.

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I have COPD and my recent lung function test shows FEV1 greater than 50% of the normal prediction.

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I have been recently diagnosed with multiple myeloma.

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I had hepatitis C but have been treated and cured.

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My side effects from the first treatment are mild now.

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I've had only one round of chemotherapy and limited steroids for my myeloma.

Exclusion Criteria

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

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I am using effective birth control and do not plan to conceive.

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I have not had treatments outside my initial therapy plan, including stem cell transplant.

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I haven't had moderate or severe asthma, or uncontrolled asthma in the last 2 years.

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I am a man and I do not plan to father children because I practice true abstinence.

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I am not pregnant or breastfeeding.

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I am not on any other chemotherapy or experimental treatments.

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I do not have severe nerve damage or mild nerve damage with pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Consolidation overall survival

Secondary study objectives

Consolidation progression-free survival

FACT-Ntx TOI recovery rate (Patient reported outcome [PRO])

Other study objectives

Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome)

Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO)

PRO completion rate

+2 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

50%

Thrombocytopenia

45%

Anaemia

39%

Nausea

29%

Decreased appetite

29%

Diarrhoea

27%

Weight decreased

24%

Neuropathy peripheral

24%

Vomiting

23%

Fatigue

21%

Neutropenia

21%

Cataract

15%

Asthenia

12%

Upper respiratory tract infection

11%

Pyrexia

11%

Constipation

Oedema peripheral

Pneumonia

Lymphopenia

Dizziness

Insomnia

Dehydration

Back pain

Leukopenia

Bronchitis

Cough

Acute kidney injury

Abdominal pain

Muscular weakness

Lower respiratory tract infection

Pain in extremity

Sepsis

Hyperglycaemia

Urinary tract infection

Nasopharyngitis

Hyponatraemia

Toothache

Disturbance in attention

Cardiac failure

Hypertension

Blood uric acid increased

Cardiac failure acute

Pulmonary contusion

Peripheral swelling

Blood creatinine increased

Paraesthesia

Infection

Respiratory syncytial virus infection

Dyspepsia

Syncope

Clostridium difficile infection

Compression fracture

Multiple fractures

Myocardial infarction

C-reactive protein increased

Cerebral haemorrhage

Ischaemic stroke

Sudden death

Oropharyngeal pain

Cognitive disorder

Confusional state

Influenza

Septic shock

Osteonecrosis of jaw

Taste disorder

Hyperkalaemia

Depression

Cerebrovascular accident

Bronchitis viral

Embolism

Haemoglobin decreased

100%

80%

60%

40%

20%

Study treatment Arm

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SdX Arm: Selinexor + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)Experimental Treatment5 Interventions

CONSOLIDATION: Patients receive bortezomib SC on days 1, 8, and 15, daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (daratumumab, lenalidomide, dexamethasone)Active Control4 Interventions

INDUCTION: All patients receive standard induction therapy comprising the following: daratumumab subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide orally (PO) daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Arm C (daratumumab, lenalidomide, dexamethasone)Active Control4 Interventions

CONSOLIDATION: Patients receive daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21, and daratumumab SC on day 1. Cycles repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Lenalidomide

2005

Completed Phase 3

~2240