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Immunomodulatory Agent
CC-220 Combination Therapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
Study Summary
This trial is testing a new drug, CC-220, for multiple myeloma, a cancer of the blood. The trial will test different doses of the drug, either alone or in combination with other drugs, to see what is safe and effective.
Who is the study for?
This trial is for adults with Multiple Myeloma, either newly diagnosed and untreated (NDMM) or those whose disease has returned after treatment (RRMM). They must be in fairly good health overall, as indicated by an ECOG score of 0-2. People who have had other cancers within the last 5 years or have a significant medical condition that could interfere with the study cannot participate.Check my eligibility
What is being tested?
The trial is testing different doses and combinations of a drug called CC-220 alone or with other treatments like Dexamethasone, Daratumumab, Bortezomib, and Carfilzomib. It's divided into two parts: finding the right dose and then expanding to more patients at that dose to see how well it works for both new and returning cases of Multiple Myeloma.See study design
What are the potential side effects?
Possible side effects include reactions where the drugs are given, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, nerve damage causing pain or weakness especially in hands and feet (neuropathy), liver issues, and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma and have not received any treatment.
Select...
I am not planned for or eligible for stem cell transplant as my initial treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment
Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment
Overall response rate (ORR) of CC-220 in combination with Dexamethasone (DEX) in Cohort D
Secondary outcome measures
Adverse Events (AEs)
Duration of Response (DOR)
Overall Survival (OS) in Part 2 relapsed and refractory multiple myeloma (RRMM) cohorts
+7 moreSide effects data
From 2021 Phase 2 trial • 289 Patients • NCT0316148317%
Urinary tract infection
14%
Upper respiratory tract infection
14%
Vomiting
14%
Diarrhoea
12%
Pharyngitis
12%
Nasopharyngitis
10%
Bronchitis
10%
Influenza
10%
Oral herpes
7%
Leukopenia
7%
Nausea
7%
Hypertriglyceridaemia
7%
Pyrexia
7%
Headache
7%
Anaemia
5%
Abdominal pain upper
5%
Back pain
5%
Hypertension
5%
Neutropenia
2%
Cholangitis
2%
Septic shock
2%
Suture related complication
2%
Cardiac tamponade
2%
Implant site pain
2%
Traumatic fracture
2%
Sinusitis
2%
Osteoarthritis
2%
Pruritus
2%
Oropharyngeal pain
2%
Acute kidney injury
2%
Pericarditis
2%
Cholelithiasis
2%
Ischaemic stroke
2%
Abnormal uterine bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.15mg QD
0.30mg QD
0.45mg QD
Active Treatment Phase 0.30mg Following Placebo
Active Treatment Phase 0.45mg Following Placebo
Placebo
Trial Design
12Treatment groups
Experimental Treatment
Group I: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2Experimental Treatment3 Interventions
Oral CC-220 at 1.0mg, 1.3mg or 1.6mg from Days 1-21 of each 28-day cycle.
Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15, and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.
Group II: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2Experimental Treatment3 Interventions
Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle.
Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.
Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle.
Group III: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2Experimental Treatment3 Interventions
Oral CC-220 at 1.0mg, 1.3mg or 1.6mg administered at cycles 1 to 8 on Days 1 to 14 of each 21-day cycle and cycles ≥ 9 on Days 1 to 21 of each 28-day cycle.
Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle.
Group IV: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2Experimental Treatment2 Interventions
Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle
Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Group V: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1Experimental Treatment3 Interventions
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle.
Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. The DEX dose will be 20 mg.
Group VI: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1Experimental Treatment3 Interventions
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, and 15 of each 28-day cycle.
Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects > 75 years old, the DEX dose will be 20 mg
Group VII: Cohort F: CC-220 with DEX and bortezomib - Part 1Experimental Treatment3 Interventions
Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle.
Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle.
Subcutaneous BTZ at dose 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, and 8 at cycle ≥9 of each 21-day cycle.
Group VIII: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1Experimental Treatment3 Interventions
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Intravenous DARA at dose 16mg/kg on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at a dose of Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15,and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.
Group IX: Cohort D: CC-220 in combination with Dexamethasone - Part 2Experimental Treatment2 Interventions
Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle
For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle
Group X: Cohort C: CC-220 Monotherapy in RRMM - Part 2Experimental Treatment1 Intervention
CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Group XI: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1Experimental Treatment2 Interventions
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment.
Group XII: Cohort A: CC-220 Monotherapy - Part 1Experimental Treatment1 Intervention
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 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
~1440
CC-220
2016
Completed Phase 2
~620
Bortezomib
2005
Completed Phase 2
~1140
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,439 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,331 Patients Enrolled for Multiple Myeloma
April Sorrell-Taylor, MDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,368,998 Total Patients Enrolled
72 Trials studying Multiple Myeloma
24,755 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple myeloma and have not received any treatment.My multiple myeloma does not produce detectable levels of M protein.I do not have any health issues that would stop me from joining the study.I am not planned for or eligible for stem cell transplant as my initial treatment.My multiple myeloma has worsened within 2 months after my last treatment.I have been cancer-free for over 5 years, except for multiple myeloma or certain non-invasive cancers.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1
- Group 2: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2
- Group 3: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2
- Group 4: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1
- Group 5: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1
- Group 6: Cohort D: CC-220 in combination with Dexamethasone - Part 2
- Group 7: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1
- Group 8: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2
- Group 9: Cohort C: CC-220 Monotherapy in RRMM - Part 2
- Group 10: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2
- Group 11: Cohort A: CC-220 Monotherapy - Part 1
- Group 12: Cohort F: CC-220 with DEX and bortezomib - Part 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are the focus of this research endeavor?
"Affirmative, the clinicaltrials.gov website reveals that this investigation is currently enlisting volunteers. The study was first announced on October 14th 2016 and saw its last update take place on November 27th 2022. 449 participants are needed for recruitment across 48 sites."
Answered by AI
What afflictions is CC-220 most efficacious in addressing?
"CC-220 is a go-to intervention for ophthalmia, sympathetic and branch retinal vein occlusion. It has also proven to be effective in treating macular edema and communicable diseases."
Answered by AI
Is there any availability for prospective participants to join this experiment?
"Affirmative. Online records on clinicaltrials.gov indicate that this medical trial, which was originally published on October 14th 2016, is actively enrolling patients. A total of 449 participants need to be recruited from 48 different locations."
Answered by AI
What other explorations have been conducted with regards to CC-220?
"CC-220 was first studied in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date, 1487 trials have been completed with 689 more ongoing; particularly, many of these are located within Puyallup, Washington."
Answered by AI
How many research centers are administering this study?
"Northwest Medical Specialties PLLC in Puyallup, Washington, Mount Sinai Brooklyn in Bonney Lake, New york, and Huntsman Cancer Institute at the University of Utah are amongst the many locations actively recruiting patients for this clinical trial."
Answered by AI
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