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Monoclonal Antibodies
Daratumumab + VMP for Multiple Myeloma
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who are newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >=65 years, or in participants <65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.4 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of two treatments for people with newly diagnosed multiple myeloma who are ineligible for high-dose chemotherapy and a stem cell transplant.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who can't have high-dose chemotherapy and stem cell transplant. They must meet specific health criteria, not be pregnant, agree to use two forms of birth control if they can have children, and have an ECOG score of 0-2.Check my eligibility
What is being tested?
The study tests whether adding daratumumab to the standard treatment (velcade-melphalan-prednisone) extends the time patients live without their disease getting worse compared to just the standard treatment in those new to multiple myeloma treatment.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, fatigue, nausea, nerve damage causing pain or numbness (neuropathy), low blood counts increasing infection risk or bleeding tendency, and potential heart or lung problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 65 or have health conditions that make high-dose chemotherapy with stem cell transplant risky.
Select...
I am able to care for myself and perform daily activities.
Select...
I have multiple myeloma with specific diagnostic markers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score
+12 moreSide effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Arm B (D-VMP)Experimental Treatment6 Interventions
Participants will receive velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
Group II: Treatment Arm A (VMP Alone)Active Control3 Interventions
Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velcade
2006
Completed Phase 4
~1320
Prednisone
2014
Completed Phase 4
~2370
Dexamethasone
2007
Completed Phase 4
~2590
Melphalan
2008
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,602 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,711 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,199 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,678 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have multiple myeloma with specific diagnostic markers.I have had a lung function test if I have or might have COPD.I am able to care for myself and perform daily activities.I have severe asthma or COPD with less than 50% normal lung function.I have moderate to severe nerve pain or damage.I have Waldenstrom's disease or a condition with IgM protein but no bone damage.You have HIV, hepatitis B, or a history of hepatitis C.I have undergone plasmapheresis within the last 28 days.I have undergone radiation therapy in the last 14 days.If you are a woman who could become pregnant, you need to have a negative pregnancy test within 14 days before joining the study.You have to meet specific medical test requirements outlined in the study plan.I have been diagnosed with primary amyloidosis, MGUS, or smoldering multiple myeloma.I have had treatment for multiple myeloma, but only a short emergency use of steroids.I haven't had cancer, except for certain skin cancers or cervical cancer in situ, in the last 3 years.I am over 65 or have health conditions that make high-dose chemotherapy with stem cell transplant risky.I am using two reliable birth control methods if I can have children.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm A (VMP Alone)
- Group 2: Treatment Arm B (D-VMP)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
How many willing participants are being recruited for this experiment?
"Presently, this study is not looking for candidates. Although, it's worth noting that the clinical trial was first posted on December 9th, 2014 and last updated on November 3rd, 2022. There are 826 other studies actively recruiting patients with multiple myeloma and 1065 studies for Prednisone that are actively seeking patients."
Answered by AI
Are patients able to sign up for this experiment at this time?
"This particular medical trial is no longer actively searching for patients to enroll. The study was initially posted on December 9th, 2014 and updated for the last time on November 3rd, 2022. There are 826 other trials related to multiple myeloma currently admitting patients and 1065 studies involving Prednisone that are also looking for participants."
Answered by AI
When do doctors usually recommend Prednisone?
"Prednisone is frequently given to patients with ophthalmia, sympathetic. It can also be used as part of the treatment plan for branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
How many sites are running this clinical trial?
"Currently, this clinical trial is operational at 10 sites. These locations include Los Angeles and Orange Park in California as well as Chicago in Illinois. To limit travel-related burdens, individuals are encouraged to enroll at the site that is geographically closest to them."
Answered by AI
Has the FDA looked favorably upon Prednisone in the past?
"Given that this is a Phase 3 trial with supporting data for efficacy and safety, our team at Power has estimated the safety of Prednisone to be a 3."
Answered by AI
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