Your session is about to expire
← Back to Search
Monoclonal Antibodies
Daratumumab Combination for Multiple Myeloma
Phase 2
Waitlist Available
Led By Muzaffar H Qazilbash
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have had relapsed disease prior to transplant, or undergone previous autologous stem cell transplant (ASCT), followed by relapse and at least a partial response to salvage therapy
Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of initiation of maintenance therapy assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing daratumumab, hyaluronidase-fihj, and pomalidomide to see if they work well together to treat patients with relapsed multiple myeloma.
Who is the study for?
This trial is for patients with relapsed multiple myeloma post-stem cell transplant. They must have had a partial response to salvage therapy, be within 60-180 days post-transplant, and have an ECOG status of 0-2. Key eligibility includes adequate kidney function (creatinine <= 2.5 mg/dL), platelet count >= 50,000/mm^3, neutrophil count >= 1000/mm^3, liver enzymes up to three times the normal limit, and no uncontrolled heart arrhythmias.Check my eligibility
What is being tested?
The study tests daratumumab with hyaluronidase-fihj and pomalidomide in treating relapsed multiple myeloma after stem cell transplant. Daratumumab is designed to stop cancer cells from growing by targeting specific proteins on their surface while pomalidomide aims to kill or halt the division of cancer cells.See study design
What are the potential side effects?
Potential side effects include infusion reactions related to daratumumab such as coughing or shortness of breath during administration; fatigue; nausea; diarrhea; low blood counts leading to increased infection risk; and possible liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after initial treatment but improved with further therapy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have recovered from my stem cell transplant side effects.
Select...
My heart pumps well and I don't have uncontrolled irregular heartbeats.
Select...
My white blood cell count is healthy without medication.
Select...
I had a stem cell transplant between 2 to 6 months ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of initiation of maintenance therapy assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of initiation of maintenance therapy assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission rate (CRR) defined as achieving a negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow
Progression-free survival (PFS)
Side 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%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Pain in extremity
14%
Lymphopenia
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%
Bone pain
9%
Leukopenia
9%
Urinary tract infection
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Alanine aminotransferase increased
8%
Abdominal pain upper
8%
Weight decreased
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Aspartate aminotransferase increased
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
5%
Bone Pain
5%
Throat irritation
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Humerus fracture
1%
Squamous cell carcinoma of skin
1%
Pneumonia cytomegaloviral
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Acute myocardial infarction
1%
Pulmonary sepsis
1%
Pathological fracture
1%
Febrile neutropenia
1%
Pleural effusion
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Femur fracture
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Gastroenteritis
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: Treatment (daratumumab)Experimental Treatment1 Intervention
Beginning 60-120 days after transplant, participants receive daratumumab IV over 4-8 hours on days 1, 8, 15 and 22 of courses 1 and 2 and days 1 and 15 of courses 3-6, then on day 1 of subsequent courses. Courses repeat every 28 days for 3 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,447 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,804 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,638 Previous Clinical Trials
40,929,806 Total Patients Enrolled
575 Trials studying Multiple Myeloma
189,106 Patients Enrolled for Multiple Myeloma
Muzaffar H QazilbashPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzyme levels are not more than three times the normal limit.I have not had radiotherapy in the last 14 days.I am currently pregnant or breastfeeding.I have tested positive for hepatitis B surface antigen or have resolved hepatitis B.I have had severe or moderate asthma in the last 2 years and it's currently not under control.I still have moderate side effects from my last chemotherapy.My condition worsened after initial treatment but improved with further therapy.I have not had major surgery in the last 2 weeks.You have tested positive for HIV.You have hepatitis C, unless you have been successfully treated for it and have no detectable virus in your blood for at least 12 weeks after treatment.My condition did not improve with daratumumab and pomalidomide treatment.I had side effects from daratumumab or pomalidomide that I couldn't tolerate.I can take care of myself and am up and about more than half of my waking hours.I have asthma or COPD with severe lung function restriction.I haven't needed IV antibiotics in the week before starting treatment.I have recovered from my stem cell transplant side effects.My heart pumps well and I don't have uncontrolled irregular heartbeats.Your creatinine level in your blood is less than or equal to 2.5 mg/dL within 5 days before starting the study drug.Your platelet count is at least 50,000 per cubic millimeter within 5 days before starting the study drug.My cancer has spread to my brain or spinal cord.My condition does not produce measurable proteins, or I have plasma cell leukemia, or I've had a previous transplant from a donor.My white blood cell count is healthy without medication.I had a stem cell transplant between 2 to 6 months ago.I cannot or will not follow the medication plan.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Daratumumab received authorization from the FDA?
"The safety profile of Daratumumab was assigned a rating of 2, since this is an early-stage clinical trial and the evidence suggests it is safe, although there has been no indication that it is efficacious."
Answered by AI
What other research projects have been completed utilizing Daratumumab?
"At this time, there are 140 active trials for Daratumumab. Of those studies, 26 have progressed to the third phase of clinical trial consents. The research is largely centred around Harrison New york; however, there are 5561 other sites where patients can participate in these experiments."
Answered by AI
What illnesses can be managed using Daratumumab?
"Daratumumab, a type of biological response modifier, is capable of treating multiple myeloma that has become refractory or relapsed."
Answered by AI
Exactly how many persons are enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov indicates that this research is actively seeking volunteers, as it was initially posted on April 11th 2019 and recently modified on September 29th 2022. 56 participants are currently being recruited from one clinical centre."
Answered by AI
Are there still opportunities for individuals to participate in this experiment?
"According to the clinicaltrials.gov page, recruitment for this research is ongoing with a commencement date of April 11th 2019 and most recent update on September 29th 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger