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Ipilimumab for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Gunjan Shah, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky (adult) Performance Status ≥ 70%.
Cardiac: LVEF at rest must be ≥ 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test the safety of ipilimumab as maintenance therapy for people with relapsed/refractory multiple myeloma who have received chemotherapy and allogeneic hematopoietic stem cell transplant.

Eligible Conditions
  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose of Ipilimumab
Phase II: Progression Free Survival (PFS)

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Lung abscess
1%
Cerebrovascular accident
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ipilimumab After Stem Cell TransplantationExperimental Treatment1 Intervention
The patient will be admitted to a single room on the Adult Transplantation Service and allogeneic CD34-selected PBSC or marrow transplantation performed as per MSKCC adult BMT guidelines. Patients will be evaluated at approximately day 100 (±2 weeks) after allo-HSCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,805 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,164 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,533 Total Patients Enrolled
84 Trials studying Multiple Myeloma
29,675 Patients Enrolled for Multiple Myeloma
Gunjan Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
105 Total Patients Enrolled
2 Trials studying Multiple Myeloma
73 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this medical experiment?

"This trial seeks 45 individuals with relapsed or refractory multiple myeloma, aged 21 to 73 years old. To be considered for the study, potential participants must qualify by meeting these criteria: fall between two lines of therapy and eligible for CD34-selected HSCT according to MSKCC adult BMT guidelines; have a 10/10 matched donor; age over 21 but under 73; and diagnose as having at least 2 prior therapies leading to very good partial remission in most recent salvage therapy."

Answered by AI

Are there a multitude of locations administering this experiment in the city?

"Presently, 7 medical centers are involved in administering this trial. Such venues include Memorial Sloan Kettering Commack (Limited Protocol Activities) in Commack and Harrison's Memorial Sloan Kettering Westchester (Limited Protocol Activities), as well as Montvale's Memorial Sloan Kettering Bergen (Limited Protocol Activities). There are also 4 other sites taking part."

Answered by AI

What other medical tests have been conducted with Ipilimumab?

"Currently, there are 318 ongoing trials for Ipilimumab. 38 of these clinical studies have attained Phase 3 status and take place primarily in Pittsburgh, Pennsylvania; however, 20362 research centres around the world are running their own investigations on this treatment."

Answered by AI

How many individuals are being enrolled in this medical research?

"Affirmative. As per the information on clinicaltrials.gov, this research project is currently looking for participants and was initially posted on November 12th 2020 with its latest update occurring on January 21st 2022. It requires 45 patients from 7research sites to complete their study."

Answered by AI

How is Ipilimumab typically utilized to assist in patient treatment?

"Ipilimumab is a common therapy for cutaneous melanoma, and it also has efficacy when treating conditions such as complete resection, liver carcinoma, and metastatic melanoma."

Answered by AI

Is this study recruiting participants at the present time?

"Affirmative. According to clinicaltrials.gov, this trial launched on November 12th 2020 and is actively searching for participants. A total of 45 patients will be recruited across 7 different sites."

Answered by AI

Is this research endeavor open to those who have attained the age of twenty or above?

"Patients that meet the qualifications for this clinical trial need to be between 21 and 73 years old. Additionally, there are 59 trials available specifically designed for minors while 1108 have been created with elderly individuals in mind."

Answered by AI
~1 spots leftby Mar 2025