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Monoclonal Antibodies
Daratumumab for Multiple Myeloma
Phase 2
Waitlist Available
Led By Sikander Ailawadhi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 at registration
Pathologically confirmed diagnosis of multiple myeloma who are transplant eligible and have received any prior induction therapy (with or without maintenance)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year (12 cycles) of daratumumab and lenalidomide maintenance
Awards & highlights
Study Summary
This trial is testing how well daratumumab works in treating patients with multiple myeloma who are eligible for a transplant. Daratumumab is an antibody that may help to stop cancer cells from growing and spreading.
Who is the study for?
This trial is for transplant-eligible patients with multiple myeloma who have had prior therapy but not daratumumab. They must show measurable cancer markers, be in decent physical condition (ECOG 0-2), and have adequate organ function. Pregnant or breastfeeding women, those unwilling to use contraception, or individuals with certain medical conditions like severe infections, heart issues, or other cancers are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of daratumumab in treating multiple myeloma in patients eligible for a stem cell transplant. Daratumumab is an antibody that targets cancer cells to prevent their growth. The trial includes autologous hematopoietic stem cell transplantation and lenalidomide as part of the treatment process.See study design
What are the potential side effects?
Daratumumab can cause side effects such as infusion reactions (symptoms similar to allergic reactions during administration), fatigue, nausea, bone marrow suppression leading to low blood counts which increases infection risk, and potential liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have multiple myeloma and am eligible for a transplant after receiving initial treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year (12 cycles) of daratumumab and lenalidomide maintenance
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year (12 cycles) of daratumumab and lenalidomide maintenance
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of minimal residual disease (MRD) negative response after autologous stem cell transplantation (ASCT)
Secondary outcome measures
Incidence of adverse events
Overall response rate
Progression-free survival
+3 moreOther outcome measures
Antibody-dependent cellular phagocytosis and antibody-dependent cell-mediated cytotoxicity
Immune repertoire profiling
MRD assessed using flow cytometry (MPF) and next generation sequencing (NGS)
+1 moreSide effects data
From 2022 Phase 3 trial • 665 Patients • NCT0056756784%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
65900-Pleural effusion
3%
57600-Nausea
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
66300-Pneumonitis
1%
42600-Hypoalbuminemia
1%
26600-Duodenal obstruction
1%
69700-Rash maculo-papular
1%
23000-Confusion
1%
71500-Respiratory failure
1%
34000-Fibrinogen decreased
1%
45800-INR increased
1%
73900-Serum amylase increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab, ASCT, lenalidomide)Experimental Treatment3 Interventions
CONSOLIDATION I: Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION II: Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT.
MAINTENANCE: Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800
Daratumumab
2014
Completed Phase 3
~1990
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,321 Total Patients Enrolled
584 Trials studying Multiple Myeloma
189,270 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,618 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,661 Patients Enrolled for Multiple Myeloma
Sikander AilawadhiPrincipal InvestigatorMayo Clinic
7 Previous Clinical Trials
4,106 Total Patients Enrolled
4 Trials studying Multiple Myeloma
712 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with daratumumab.I have not needed IV antibiotics for an infection in the last 14 days.My multiple myeloma is measurable by specific medical criteria.My condition is either non-secretory multiple myeloma or AL amyloidosis.I am of childbearing age and do not plan to use birth control.I have had a stem cell transplant for multiple myeloma.I had cancer before, but it was either skin cancer, in situ, early stage and treated, or any cancer I've been free of for 3+ years.I have not had major surgery in the last 4 weeks.I have not had a stroke or brain bleed in the last 6 months.I do not have severe heart problems or recent heart attacks.I have severe COPD or asthma with low lung function.I can take care of myself and am up and about more than half of my waking hours.I am HIV positive.I am not planning to receive any experimental treatments or radiation therapy, except for palliative care.I have been diagnosed with hepatitis B or C.My white blood cell count is healthy without needing medication.I have multiple myeloma and am eligible for a transplant after receiving initial treatment.Your bilirubin levels should not be too high, unless it is caused by a condition called Gilbert's syndrome.My liver function tests are within normal limits.My kidney function test shows a creatinine clearance of at least 30 ml/min.My blood clotting time is within the normal range.My multiple myeloma has spread to the lining of my brain and spinal cord.You are eligible for a transplant.Your platelet count is at least 50,000 cells/mm^3 if your bone marrow plasmacytosis is less than 50%, or at least 30,000 cells/mm^3 if your bone marrow plasmacytosis is 50% or more, and the test was done within the last 14 days before you join the study.You have detectable cancer cells in your bone marrow within the past 28 days.I have severe nerve damage or POEMS syndrome.Women who can become pregnant must have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab, ASCT, lenalidomide)
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.
Are opportunities available for individuals to enroll in this research?
"This medical trial is no longer seeking new participants; it was initially posted on April 9th 2018, and its most recent update was March 25th 2022. However, there are 818 studies that are presently accepting patients with multiple myeloma and 360 for Autologous Hematopoietic Stem Cell Transplantation."
Answered by AI
Has the Autologous Hematopoietic Stem Cell Transplantation procedure been sanctioned by the FDA?
"Our team considers Autologous Hematopoietic Stem Cell Transplantation to be moderately safe, as evidenced by a score of 2. This is based on the Phase 2 status of this medical trial which features some safety data but none documenting efficacy."
Answered by AI
Are there any other works in the scientific literature related to Autologous Hematopoietic Stem Cell Transplantation?
"Currently, there are 360 active studies for Autologous Hematopoietic Stem Cell Transplantation, with 70 being in the third phase. The Windy City is a center of research related to this treatment; however, it can be found across 15,958 sites internationally."
Answered by AI
What are the most common applications of Autologous Hematopoietic Stem Cell Transplantation?
"Autologous Hematopoietic Stem Cell Transplantation has been employed to treat chronic lymphocytic leukemia, as well as a variety of other maladies such as immunomodulation, exposure to previous chemotherapy regimens, and amyloidosis."
Answered by AI
How many individuals have been accepted to participate in this clinical experiment?
"At this point in time, there is no need for new participants to join this trial. It was initially published on April 9th 2018 and last updated March 25th 2022. For those looking into other clinical trials, 818 studies involving multiple myeloma are actively enrolling patients and 360 Autologous Hematopoietic Stem Cell Transplantation related trials have open recruitment."
Answered by AI
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