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Daratumumab After Stem Cell Transplant for Multiple Myeloma
Phase 2
Waitlist Available
Led By Amrita Y Krishnan
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) =< 2
Calculated creatinine clearance >= 30 mL/min
Must not have
Prior disease progression with daratumumab or other anti-CD38 antibody
History of organ or previous autologous/allogeneic stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Summary
This trial studied how well daratumumab works in treating patients with multiple myeloma after a stem cell transplant. Monoclonal antibodies kill cancer cells that are left after chemotherapy.
Who is the study for?
This trial is for patients with multiple myeloma who have adequate organ function, no severe asthma or uncontrolled diseases, and are not pregnant. They must understand the study and agree to use birth control. Participants should be within 2-13 months of their first therapy for multiple myeloma and have a sufficient number of stem cells collected for transplant.
What is being tested?
The trial tests daratumumab's effectiveness following a stem cell transplant in treating multiple myeloma. Daratumumab is an antibody that may destroy remaining cancer cells post-chemotherapy. The study includes autologous stem cell transplantation, melphalan chemotherapy, and biomarker analysis.
What are the potential side effects?
Daratumumab can cause immune system reactions such as infusion-related responses, fatigue, nausea, bone marrow suppression leading to low blood counts which increases infection risk, and potential allergic reactions.
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 50% of my waking hours.
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My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition worsened after treatment with daratumumab or a similar drug.
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I have had an organ or stem cell transplant in the past.
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I am not pregnant or breastfeeding.
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I do not have an uncontrolled infection.
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I am HIV positive.
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I have not had major surgery in the last 2 weeks.
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I have serious heart issues, including recent heart attack or unstable angina.
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I have had plasma cell leukemia or cancer that spread to my brain or spinal cord.
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I currently have hepatitis A.
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I have a rare blood disorder such as plasma cell leukemia or Waldenstrom's macroglobulinemia.
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I have COPD with less than half the normal lung function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival
Secondary study objectives
Clinical benefit response based on the IMWG criteria
Depth of response
Overall response rate (stringent complete response [sCR]/complete response [CR], very good partial response [VGPR]) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
+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%
57600-Nausea
3%
65900-Pleural effusion
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%
42600-Hypoalbuminemia
1%
34000-Fibrinogen decreased
1%
71500-Respiratory failure
1%
73900-Serum amylase increased
1%
23000-Confusion
1%
26600-Duodenal obstruction
1%
66300-Pneumonitis
1%
69700-Rash maculo-papular
1%
45800-INR 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 (ASCT, melphalan, daratumumab)Experimental Treatment4 Interventions
Patients undergo standard of care ASCT with a conditioning regimen of melphalan. Beginning 60-120 days after ASCT, patients receive daratumumab IV every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 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
~2090
Daratumumab
2014
Completed Phase 3
~2000
Melphalan
2008
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,506 Total Patients Enrolled
38 Trials studying Multiple Myeloma
3,484 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,969 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,326 Patients Enrolled for Multiple Myeloma
Amrita Y KrishnanPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a stem cell transplant with a specific chemotherapy dose, adjusted for my kidney function.My organs are strong enough for high dose chemotherapy and a stem cell transplant.I've been cancer-free for 5 years, except for minor skin cancers or early-stage prostate or breast cancer.I have been diagnosed with multiple myeloma, amyloidosis included.You have known allergies or sensitivity to certain types of medications made from human proteins.You have been infected with hepatitis C, unless you have been successfully treated for it.I started my first treatment for multiple myeloma between 2 and 13 months ago.Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your alanine aminotransferase (ALT) level should be no more than 3 times the upper limit of normal.My condition worsened after treatment with daratumumab or a similar drug.I have had an organ or stem cell transplant in the past.I am HIV positive.I have been tested for hepatitis B and know my status.I am a man who will use birth control and not donate sperm during and 6 months after the study.I haven't taken antibiotics for an infection in the last 14 days.I do not have an uncontrolled infection.I am not pregnant or breastfeeding.My multiple myeloma has worsened before joining this study.I have moderate or severe asthma, or my asthma is currently not under control.I have had an autoimmune or inflammatory disorder in the last 3 years, except for stable hypothyroidism, vitiligo, alopecia, or untreated psoriasis.I have not had major surgery in the last 2 weeks.You have a history of a weakened immune system from birth.I have not received any live vaccines in the last 4 weeks.Your AST levels are not more than three times the normal limit.You have enough infection-fighting white blood cells in your body.I can take care of myself and am up and about more than 50% of my waking hours.I am currently on chemotherapy, biologic, or hormonal therapy for cancer.I have serious heart issues, including recent heart attack or unstable angina.I have had plasma cell leukemia or cancer that spread to my brain or spinal cord.You need to have enough CD34+ cells, at least 2.5 million per kilogram of your body weight.I currently have hepatitis A.I have a rare blood disorder such as plasma cell leukemia or Waldenstrom's macroglobulinemia.I have COPD with less than half the normal lung function.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I am using a reliable birth control method or my partner is sterilized.I haven't used strong immune-suppressing drugs recently, except for minor exceptions like creams or low-dose steroids.My platelet count is at least 75,000 without recent transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ASCT, melphalan, 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.
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