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Proteasome Inhibitor

Quadruple Drug Therapy for Multiple Myeloma

Phase 2
Recruiting
Led By Ajai Chari, MD
Research Sponsored by Larysa Sanchez
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed, untreated, symptomatic MM as defined by standard criteria with clonal bone marrow plasma cells >10% or biopsy-proven bony or extramedullary plasmacytoma
Be older than 65 years old
Must not have
Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of study drug
Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within a year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment in elderly patients with multiple myeloma who are not eligible for a transplant. The treatment consists of four drugs given in different combinations and doses. Patients will be monitored closely for side effects and how well the treatment works.

Who is the study for?
This trial is for people aged 70 or older with newly diagnosed multiple myeloma who can't have a stem cell transplant. They should be able to perform daily activities (ECOG ≤ 2) and have measurable disease indicators. Men must use contraception if sexually active with women of childbearing potential. People are excluded if they have certain heart, lung, kidney diseases, infections, severe allergies to the drugs being tested, or other health conditions that could affect drug absorption or pose risks.
What is being tested?
The study tests a combination of subcutaneous daratumumab with lower doses of bortezomib, lenalidomide (revlimid), and dexamethasone in elderly patients who cannot undergo transplantation. The treatment continues until disease progression or unacceptable side effects occur while monitoring for safety and effectiveness.
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk; nerve damage causing pain or numbness; digestive issues like nausea; fatigue; allergic reactions to medication components; and potential heart complications.

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 and have not received treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a GI condition or had a procedure that may affect drug absorption.
Select...
I have had severe asthma in the last 2 years or currently have uncontrolled asthma.
Select...
I have had a spine surgery within the last week.
Select...
I am allergic to bortezomib, lenalidomide, dexamethasone, or daratumumab.
Select...
I do not have serious heart conditions or recent heart attacks.
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I haven't needed antibiotics for an infection in the last 14 days.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I am a man and agree to use two forms of birth control.
Select...
My lung function is less than half of what is expected for someone my age and size.
Select...
I have been diagnosed with primary amyloidosis.
Select...
I have severe nerve damage or moderate damage with pain.
Select...
My kidney function is very low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within a year
This trial's timeline: 3 weeks for screening, Varies for treatment, and within a 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
Responses: VGPR or better
Secondary study objectives
Duration of ORR (≥PR), ≥VGPR, ≥CR, and sCR
Number of Adverse Events
Overall Response Rates
+4 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%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Headache
6%
Arthralgia
6%
Paraesthesia
6%
Bronchitis
5%
Bone pain
5%
Bone Pain
5%
Decreased Appetite
5%
Hypocalcaemia
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Epistaxis
5%
Decreased appetite
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Alanine aminotransferase increased
4%
Hypotension
4%
Abdominal pain
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Hypertension
3%
Rash
3%
Abdominal Pain Upper
3%
Hypophosphataemia
3%
Influenza
3%
Abdominal pain upper
3%
Conjunctivitis
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Urinary tract infection
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Herpes Zoster
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Lower respiratory tract infection
1%
Syncope
1%
Productive cough
1%
Nasal congestion
1%
Respiratory failure
1%
Weight decreased
1%
Chills
1%
Gastroenteritis
1%
Sepsis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
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

1Treatment groups
Experimental Treatment
Group I: Daratumumab with dose-attenuated VRdExperimental Treatment5 Interventions
SubQ Daratumumab with Dose-Attenuated VRd
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Ixazomib
2017
Completed Phase 4
~3510
Lenalidomide
2005
Completed Phase 3
~2240
Bortezomib
2005
Completed Phase 3
~1410
Daratumumab
2014
Completed Phase 3
~2380

Find a Location

Who is running the clinical trial?

Larysa SanchezLead Sponsor
Ajai ChariLead Sponsor
4 Previous Clinical Trials
85 Total Patients Enrolled
4 Trials studying Multiple Myeloma
85 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
310,367 Total Patients Enrolled
25 Trials studying Multiple Myeloma
9,645 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04052880 — Phase 2
Multiple Myeloma Research Study Groups: Daratumumab with dose-attenuated VRd
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04052880 — Phase 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04052880 — Phase 2
~0 spots leftby Dec 2024
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