Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Immunomodulating Agents

Lenalidomide

Bortezomib

Dexamethasone acetate

BB 1101

Proteasome Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

CXCR4 inhibitor given weekly on a 28 day cycle intravenously

Ulocuplumab

immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib

proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide

steroid given at physician discretion on a 28 day cycles

Irene M Ghobrial, MD

Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657

This research study is an Expanded Access Trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available.

The purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab.

Participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. Ulocuplumab is supposed to kill myeloma cells.

Lenalidomide, which is also known as Revlimid® and Bortezomib, which is also known as Velcade®, are approved by the FDA for treatment of Multiple Myeloma. Dexamethasone, also known as Decadron®, is also approved by the FDA for other treatments. It is a type of steroid medication that fights inflammation.

Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma

Bristol-Myers Squibb

Dana-Farber Cancer Institute

Irene M. Ghobrial, MD

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

* Intervention model: Single group for Stage 1 DLT, then Parallel
* Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors

A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors

The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.

ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.

If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.

The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.

The number of participants experiencing electrocardiogram abnormalities was reported for each arm

Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.

Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W

PAC DL1 (DLT)

Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W

PAC DL-1 (Tot)

All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W

SCLC (Tot)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

Adverse Events

Serious Adverse Events

Immune-mediated AEs

All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs

All treated participants in PAC arms. ORR data was not collected for SCLC arm.

Objective Response Rate (ORR) Per RECIST 1.1 Criteria

OS data was not collected for any participants

Overall Survival (OS)

Increased lymphocytes

Decreased platelet count

Hemoglobin

Leukocytes

Neutrophils

Platelet Count

Alanine Aminotransferase

Alkaline Phosphatase

Aspartate Aminotransferase

Bilirubin

Creatine

Hypernatremia

Hyponatremia

Hypermagnesemia

Hypomagnesemia

Hypercalcemia

Hypocalcemia

Hyperkalemia

Hypokalemia

Amylase

Lipase

All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma	NCT02666209	Multiple Myelom... Multiple Myelom...	Ulocuplumab Lenalidomide Bortezomib Dexamethasone	18 Years -	Dana-Farber Cancer Institute
Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors	NCT02472977	Solid Tumor	Ulocuplumab Nivolumab	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for ulocuplumab

Every month we try and update this database with for ulocuplumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ulocuplumab

Every month we try and update this database with for ulocuplumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ulocuplumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.