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Pleiotropic Pathway Modulator
CC-122 for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 6 months
Awards & highlights
Study Summary
This trial is to test the safety and effectiveness of a new drug for people with advanced tumors that haven't responded to other treatments. They'll also be finding out what the best dose is and how often it should be taken.
Eligible Conditions
- Multiple Myeloma
- Lymphoma
- Diffuse Large B-Cell Lymphoma
- Pleiotropic Pathway Modifier
- Glioblastoma
- Central Nervous System Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD)
Non-tolerated dose (NTD)
+6 moreSecondary outcome measures
6-month progression free survival (PFS) rate for GBM chort
Response Rate
Tissue concentration of CC-122
Side effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT0331061962%
Neutropenia
54%
Thrombocytopenia
46%
Fatigue
38%
Nausea
38%
Anaemia
38%
Dizziness
31%
Back pain
31%
Leukopenia
23%
Decreased appetite
23%
Lymphopenia
23%
Hypophosphataemia
23%
Diarrhoea
23%
Arthralgia
23%
Cytokine release syndrome
23%
Constipation
15%
Night sweats
15%
Weight decreased
15%
Neurotoxicity
15%
Tremor
15%
Dysarthria
15%
Dysphonia
15%
Muscular weakness
15%
Cough
15%
Hypotension
15%
Contusion
15%
Vomiting
15%
Sinusitis
15%
Candida infection
15%
Ecchymosis
8%
International normalised ratio increased
8%
Mastication disorder
8%
Benign prostatic hyperplasia
8%
Erythema
8%
Confusional state
8%
Brain fog
8%
Pruritus
8%
Viral infection
8%
Joint swelling
8%
Epistaxis
8%
Dermatitis acneiform
8%
Rash
8%
Liver function test increased
8%
Deep vein thrombosis
8%
Flushing
8%
Haematoma
8%
Paraesthesia
8%
Thrombophlebitis
8%
Haemorrhage intracranial
8%
Hyperkalaemia
8%
Hyporeflexia
8%
Acute kidney injury
8%
Abdominal distension
8%
Hypoalbuminaemia
8%
Vulvitis
8%
Bone pain
8%
Atrial fibrillation
8%
Orthostatic hypotension
8%
Coccydynia
8%
Neuropathy peripheral
8%
Dry eye
8%
Non-cardiac chest pain
8%
Oedema peripheral
8%
Blood creatinine increased
8%
Resting tremor
8%
Pollakiuria
8%
Agitation
8%
Delirium
8%
Depression
8%
Libido decreased
8%
Febrile neutropenia
8%
Pneumonia
8%
Abdominal pain
8%
Mucosal inflammation
8%
Swelling
8%
Hyponatraemia
8%
Headache
8%
Gastrooesophageal reflux disease
8%
Dry skin
8%
Ileus
8%
Dry mouth
8%
Hyperbilirubinaemia
8%
Pain in extremity
8%
Urinary tract pain
8%
Colitis ischaemic
8%
Intention tremor
8%
Anxiety
8%
Prostatic specific antigen increased
8%
Haematuria
8%
Hypokalaemia
8%
Myalgia
8%
Wheezing
8%
Hypervolaemia
8%
Oropharyngeal pain
8%
Influenza
8%
Aspartate aminotransferase increased
8%
Dehydration
8%
Infusion related reaction
8%
Limb discomfort
8%
Sinus tachycardia
8%
Pain
8%
Dyspnoea
8%
Tachypnoea
8%
Gastrointestinal haemorrhage
8%
Mesenteric artery stenosis
8%
Hypocalcaemia
8%
Hypomagnesaemia
8%
Rhinitis allergic
8%
Upper-airway cough syndrome
8%
Rash pruritic
8%
Alanine aminotransferase increased
8%
Rhinorrhoea
8%
Cerumen impaction
8%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Primary Central Nervous System Lymphoma (PCNSL)Experimental Treatment1 Intervention
During dose expansion of selected intermittent schedules, an additional cohort of up to 10 subjects with PCNSL will also be explored at the same dose and schedule as DLBCL to confirm some safety and preliminary efficacy signal
Group II: CC-122- GBM-2Experimental Treatment1 Intervention
A new GBM cohort (GBM-2) in order to evaluate doses of CC-122 above the 3 mg QD MTD determined in all comers in Part A. CC-122 dose will increase in 1 mg increments starting with 4 mg daily on a continuous schedule using the 3+3 design described in Part A in order to establish an MTD specific for GBM subjects. Following dose escalation, the cohort will be expanded at or below the new MTD in up to 20 total subjects.
Group III: CC-122- DLBCL-2Experimental Treatment1 Intervention
A new DLBCL cohort (DLBCL-2) in order to evaluate intermittent schedules of CC-122 (5 continuous days out of 7 days per week [5/7 days] and/or 21 continuous days out of 28 days per cycle [21/28 days]). Doses to be explored include 4 mg and 5 mg on an intermittent schedule using the 3+3 design described in Part A in order to establish an MTD for the intermittent dosing schedules. Following dose escalation, one or more intermittent dosing schedules may be expanded at or below the new intermittent schedule MTD in at least 20 total subjects per dosing schedule.
Group IV: CC-122 MM-2Experimental Treatment1 Intervention
A new MM cohort (MM-2) will be enrolled in order to evaluate tolerability, safety and preliminary efficacy of the CC-122 formulated capsule given on an intermittent schedule (5/7 days per week) in 2 parallel dose escalation cohorts (MM-2a and MM-2b, respectively) (DEX) in Pomalidomide naïve subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avadomide
Not yet FDA approved
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
640 Previous Clinical Trials
130,120 Total Patients Enrolled
144 Trials studying Multiple Myeloma
41,828 Patients Enrolled for Multiple Myeloma
Michael Pourdehnad, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
174 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,512 Previous Clinical Trials
3,371,091 Total Patients Enrolled
73 Trials studying Multiple Myeloma
25,634 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have GBM, you don't need to have visible signs of the disease to participate in the study.You had any other type of cancer within the past 5 years, except for certain cases.You have a serious heart condition.You have other serious or uncontrolled health conditions at the same time.You have had a solid organ transplant in the past.Any health condition that could make it difficult to understand the results of the study.You have cancer that has not responded to or you cannot tolerate standard treatments. You must have measurable signs of the disease.You have cancer that has spread to your brain and it is causing symptoms, except if you have certain types of brain cancer (GBM or PCNSL).You have been diagnosed with a specific type of cancer (DLBCL-2, PCNSL, GBM-2, or Multiple Myeloma) that the study is focusing on.
Research Study Groups:
This trial has the following groups:- Group 1: CC-122- GBM-2
- Group 2: CC-122- DLBCL-2
- Group 3: CC-122 MM-2
- Group 4: Primary Central Nervous System Lymphoma (PCNSL)
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 CC-122 been given the regulatory go-ahead by the Food and Drug Administration?
"As CC-122 is being tested in its earliest stages, the safety rating of this drug stands at a 1 due to an absence of substantial data on both efficacy and toxicity."
Answered by AI
What is the total number of participants involved in this clinical trial?
"This clinical trial is not accomodating applicants presently. It was initially launched on September 12th 2011 and the most recent amendment to it occured on October 27th 2022. For those seeking other trials, 2905 studies related to lymphoma are actively recruiting patients as well as 5 more that involve CC-122 specifically."
Answered by AI
In which geographical areas has this clinical trial been implemented?
"The medical research is available in 17 different sites, including Swedish Medical Center Cancer Institute Research (Seattle), Local Institution - 020 (New york) and Henry Ford Medical Center - New Center One (Detroit)."
Answered by AI
Are there any other investigations involving CC-122 that have been conducted previously?
"The first clinical trial involving CC-122 was conducted at A.O.U. di Bologna Policlinico S.Orsola-Malpighi in 2011, subsequently being replicated 8 times and 5 more trials currently active around the globe, notably Seattle, Washington."
Answered by AI
Is this the inaugural investigation of its kind?
"CC-122 has had a lengthy history of clinical trials with its initial study commencing in 2011, organised by Celgene. After being approved for Phase 1 drug use, it is now the subject of five distinct investigations that span eight countries and 38 cities."
Answered by AI
Is this research endeavor currently accepting participants?
"Clinicaltrials.gov records show that this medical trial, first uploaded on September 12th 2011 and last modified on October 27th 2022, is not recruiting new patients at the moment. Fortunately, there are 2,910 other clinical trials currently in search of participants."
Answered by AI
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