CC-220 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New York University Langone, New York, NY
Multiple Myeloma+1 More
CC-220 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma

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Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CC-220 will improve 2 primary outcomes and 14 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 28 days from start of the combination therapy.

Up to 24 months
Complete Response Rate (CRR)_ Phase 2
Month 24
Incidence of Adverse Event (AEs)
Month 24
Duration of Response (DoR)
Overall Response Rate (ORR)
Overall Survival (OS)
Pharmacokinetics - AUC0-28days _Phase 1 and 2
Pharmacokinetics - AUC_Phase 1 and 2
Pharmacokinetics - Cmax_Phase 1 and 2
Pharmacokinetics - Tlast _Phase 1 and 2
Pharmacokinetics - Tmax_Phase 1 and 2
Progression-free Survival (PFS)
Progression-free survival after next antimyeloma therapy (PFS2)
Time to next antimyeloma treatment (TTNT)
Time to response (TTR)
Day 28
Does Limiting Toxicity (DLT) rates _Phase 1
Month 4
Feasibility of maintenance therapy in combination with bb2121

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Arm B- bb2121 in combination with BMS-986405 (JSMD194)
1 of 3
Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)
1 of 3
Arm C-bb2121 in combination with Daratumumab+pomalidomide+low-dose dexamethasone...
1 of 3
Experimental Treatment

This trial requires 415 total participants across 3 different treatment groups

This trial involves 3 different treatments. CC-220 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm B- bb2121 in combination with BMS-986405 (JSMD194)bb2121 will be administered at a target dose of 450 x 10^6 CAR+T cells. The combination agent will be administered during Month 1 starting from the day of bb2121 infusion.
Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)bb2121 will be administered at a target dose of 450 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules, depending on dose limiting toxicity (DLT) evaluation.
Arm C-bb2121 in combination with Daratumumab+pomalidomide+low-dose dexamethasone or POM +bortezomibbb2121 will be administered at a target dose of 450 x 10^6 CAR+T cells. The combination agents will be administered as follow: Cohort 1 (DPd) DARA, POM and dexamethasone at M3D1 until disease progression. Cohort 2 (PVd) POM, BTZ and dexamethasone at M3D1 until disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
FDA approved
Dexamethasone
FDA approved
CC-220
Not yet FDA approved
Pomalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 months after bb2121 infusion in the respective cohort
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 months after bb2121 infusion in the respective cohort for reporting.

Closest Location

New York University Langone - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The first arm (A) is made up of people who have previously received treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody-containing regimen for at least two consecutive cycles show original
An individual has a high level of M-protein if their serum protein electrophoresis (sPEP) or urine protein electrophoresis (uPEP) level is ≥ 0.5 g/dL or if their urine protein electrophoresis level is ≥ 200 mg/24 hours show original
At least one but no more than three prior treatments with MM drugs are required for participants in Arm A Cohort 2 and Arm C. show original
Arm A Cohort 2: Participant has received prior treatment with an immunomodulatory agent show original
Evidence of PD is determined by either an increase in the size of an existing lesion, the appearance of a new lesion, or an increase in the number of lesions show original
The patient achieved a response to at least one treatment regimen in the past. show original
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of good or satisfactory. show original
Cohort 1 At least 3 different prior MM regimens were used by participants in Arm A Cohort 1 and Arm B Cohort 1. show original

Patient Q&A Section

What causes multiple myeloma?

"The aetiology of multiple myeloma is currently not well understood. However, the results showed that the MYC proto-oncogene is significantly down-regulated and methylation-linked DNA hypomethylation is associated with multiple myeloma development." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"Many patients have multiple myeloma at the time of diagnosis. When multiple myeloma is diagnosed, several treatment options are available. Treatment must first be tailored to individual patient needs, however, through clinical trials and collaborative arrangements with one of six Clinical Research Nurse Collaborative Centers (CRNCC) established by the United States Federal Government. The CRNCC Program was formulated to promote the advancement of multidisciplinary, multi-institutional clinical treatment research for patients with multiple myeloma, with an emphasis on prevention of disease progression through prevention and early detection, as well as to treat advanced disease." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Results from a recent paper of the prospective studies indicate that MM at diagnosis with a low bone marrow blast percentage is typically curable, even if the disease is refractory. Therefore, MM therapy does not have to be continued after disease remission because it is not curable." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"In the U.S. in 2001, 21,700 people got multiple myeloma, with an estimated incidence rate of 2.8 per million per year among those 65 years of age and older. However, the mortality rate in people with multiple myeloma was twice as high as in the general population: 9 people per year per million were estimated to have died in 2001. The lifetime risk of developing multiple myeloma is approximately 3% for all age groups in the U.S., and is significantly higher for people 65 years and older." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma is a cancer of the bone marrow which forms tumours in the bones of the spine, ribs, skull, and other bones. Symptoms may include heavy feeling around the shoulders, legs or bones, headache, and unexplained back pain. A number of other symptoms may also occur. It usually occurs in people over the age of sixty, but in about 5% of cases symptoms will manifest before the age of 40. In most cases the cause remains unknown and treatment consists of chemotherapy and rarely bone marrow transplants. Survival rates have improved over recent years, partly because of earlier diagnosis as well as better drug responses." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"People presenting with symptoms of a myeloproliferative disease usually have myeloma. These symptoms include progressive malaise, increased urinary frequency, night sweats, increased weight and bone pain. Other signs include low red blood cells, low platelets and enlarged lymph nodes. In more advanced cases, bone pain and renal dysfunction may develop." - Anonymous Online Contributor

Unverified Answer

What does cc-220 usually treat?

"The effectiveness and side effects of cc-220 were similar or even a bit better than nirvanon for the treatment of relapsed and refractory multiple myeloma. Further long-term trials are warranted." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple myeloma?

"People with moderate symptoms, who have not had symptomatic improvement with standard therapy, with adequate renal and liver function, and a reasonably good performance status should consider taking part in a trial. It may be that the benefit of a trial is no better than that of usual care. It should be considered when no evidence shows that current treatment is effective, when some patients consider that their current treatment may not be right for them, or when there is reasonable confidence that the new treatment will help. It is recommended to contact the principal investigator or medical writer before taking part in a clinical trial." - Anonymous Online Contributor

Unverified Answer

How serious can multiple myeloma be?

"The treatment of MM is frequently ineffective. Although multiple myeloma is uncommon in patients older than 60 years of age, it has the potential to severely impair the quality of life of those with it." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in cc-220 for therapeutic use?

"Bortezomib/dexamethasone is an effective and well-tolerated antineoplastic drug. It can produce objective responses in high-risk myeloma. It may be a valid option in high-risk and/or elderly patients, even if not yet proven to improve survival rates." - Anonymous Online Contributor

Unverified Answer

What is the latest research for multiple myeloma?

"As multiple myeloma is a serious disease with many complications, the advancement of understanding the pathogenesis of this disease should be a focus for clinical investigators." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating multiple myeloma?

"No novel discoveries have been made in the past 5 years in multiple myeloma research, though this is likely the result of the fact these patients are rarely studied in large studies; nevertheless, small clinical trials do continue to be performed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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