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Proteasome Inhibitor
DKd Regimen for Smoldering Multiple Myeloma
Phase 2
Recruiting
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the International Myeloma Working Group Criteria
Age of patients must be 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 3 years post-treatment
Awards & highlights
Study Summary
This trial is studying a combination of 3 drugs as a treatment for people with smoldering multiple myeloma.
Who is the study for?
Adults over 18 with high-risk smoldering multiple myeloma, a condition where cancer cells are present but not causing symptoms. Participants must have certain levels of M-protein and plasma cells, no severe organ damage or bone lesions, and be able to perform daily activities. Women who can bear children must use contraception.Check my eligibility
What is being tested?
The DKd treatment combines daratumumab (injection under the skin), carfilzomib (IV), and dexamethasone (oral/IV) in cycles to prevent or slow down the progression of multiple myeloma from its smoldering phase. The study includes frequent tests, scans, questionnaires, and long-term follow-up.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites for daratumumab; heart, lung, liver or kidney problems from carfilzomib; and increased blood sugar or mood changes from dexamethasone. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is confirmed as smoldering multiple myeloma.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am classified as high-risk for smoldering multiple myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 3 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 3 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate
Secondary outcome measures
Biochemical and Symptomatic progression free survival (PFS)
Durability of MRD negative complete response (CR)
Duration of Response
+3 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Oedema peripheral
20%
Arthralgia
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Musculoskeletal chest pain
10%
Muscle spasms
9%
Leukopenia
9%
Urinary tract infection
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Hypocalcaemia
7%
Herpes zoster
7%
Influenza
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Abdominal pain
6%
Aspartate aminotransferase increased
6%
Myalgia
6%
Nasal congestion
5%
Chills
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Throat irritation
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Acute kidney injury
2%
Atrial fibrillation
2%
Sepsis
2%
Atrial Fibrillation
1%
Hip fracture
1%
Femur fracture
1%
Pulmonary sepsis
1%
Lower Respiratory Tract Infection
1%
Rib fracture
1%
Pneumonia cytomegaloviral
1%
Squamous cell carcinoma of skin
1%
Acute myocardial infarction
1%
Humerus fracture
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Cerebrovascular accident
1%
Pathological fracture
1%
Ischaemic stroke
1%
Pleural effusion
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Febrile neutropenia
1%
Angina unstable
1%
Lower respiratory tract infection
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment3 Interventions
Daratumumab SC (Cycles 1-2: Days 1, 8, 15, 22; Cycles 3-6: Days 1, 15; Cycles =7: Days 1 of the 28-day cycle); Carfilzomib IV (Days 1, 8, 15 of the 28-day cycle); Dexamethasone PO/IV (Days 1, 8, 15, 22 of the 28-day cycle)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1310
Daratumumab
2014
Completed Phase 3
~1960
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,722 Previous Clinical Trials
40,964,323 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,402 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,460 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,037 Patients Enrolled for Multiple Myeloma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,105 Total Patients Enrolled
5 Trials studying Multiple Myeloma
955 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unmanaged ongoing illnesses.You have high levels of a protein called M-protein in your blood or a high percentage of plasma cells in your bone marrow.I cannot take certain medications due to adverse reactions.I don't have bone damage from cancer, except possibly one spot on my spine.The main goal of the study is to see if the disease is gone, so patients with very low levels of the disease in their blood may also be included in the study.My kidney function is normal, with creatinine below 2.0 mg/dL.My condition is confirmed as smoldering multiple myeloma.I am 18 years old or older.My organs and bone marrow are working well.I have a serious heart condition.I have had treatment for smoldering multiple myeloma, with some exceptions.I have COPD or severe asthma.I am HIV positive or have an active hepatitis B infection.I can take care of myself but might not be able to do heavy physical work.I am classified as high-risk for smoldering multiple myeloma.My blood pressure or diabetes is not well-managed.Your blood calcium level is below a certain number.Your hemoglobin level is higher than 10 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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