Trial Outcomes & Findings for A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma (NCT NCT01302366)

Last Updated: 2015-02-12

Results Overview

Response \[complete response (CR), partial response (PR), and stable disease (SD)\] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

up to 3 years

Results posted on

2015-02-12

Participant Flow

From March 2011 to October 2012, 20 patients were enrolled to the study from Perlmutter Cancer Center at NYU Lagone Medical Center.

Participant milestones

Participant milestones
Measure	Sea Cucumber Extract (TBL 12) TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Sea Cucumber Extract (TBL 12) TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Overall Study patient choice or noncompliance	5

Baseline Characteristics

A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sea Cucumber Extract (TBL 12) n=20 Participants TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression. TBL-12
Age, Customized 35-44 years	1 participants n=39 Participants
Age, Customized 45-53 years	2 participants n=39 Participants
Age, Customized 54-63 years	9 participants n=39 Participants
Age, Customized 64-73 years	5 participants n=39 Participants
Age, Customized 74-83 years	3 participants n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	12 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	2 Participants n=39 Participants
Race (NIH/OMB) White	15 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=39 Participants
Region of Enrollment United States	20 participants n=39 Participants

PRIMARY outcome

Timeframe: up to 3 years

Outcome measures

Outcome measures
Measure	Sea Cucumber Extract (TBL 12) n=20 Participants TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Duration of Response (All Treated Patients)	19.7 months Interval 2.0 to 31.0

PRIMARY outcome

Timeframe: up to 3 years

Population: All patients or the patients excluding personal choice or non-compliance

Outcome measures

Outcome measures
Measure	Sea Cucumber Extract (TBL 12) n=15 Participants TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Duration of Response (Excluding Patient Choice and Non-compliance)	21.0 months Interval 8.5 to 31.0

SECONDARY outcome

Timeframe: 2 months

Population: all patients

Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)

Outcome measures

Outcome measures
Measure	Sea Cucumber Extract (TBL 12) n=20 Participants TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Percentage of Patients Who Have Responded to TBL12	100 percentage of participants

Adverse Events

Sea Cucumber Extract (TBL 12)

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sea Cucumber Extract (TBL 12) n=20 participants at risk TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Respiratory, thoracic and mediastinal disorders Pain: Chest/thorax NOS	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Nausea	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with Grade 3 or 4 neutrophils: Skin (cellulites)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.

Other adverse events

Other adverse events
Measure	Sea Cucumber Extract (TBL 12) n=20 participants at risk TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Gastrointestinal disorders Distension/bloating, abdominal	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Pain: Abdomen NOS	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Skin and subcutaneous tissue disorders Rash: acne/acneiform:	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Psychiatric disorders Mood alteration: Agitation	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Anorexia	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Psychiatric disorders Mood alteration: Anxiety	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Joint	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Arthritis (non-septic):	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Back	45.0% 9/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Bladder (urinary)	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Metabolism and nutrition disorders Creatinine	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Bone	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Chest/thorax NOS	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Perforation, GI: Colon	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Constipation	35.0% 7/20 • up to one year All adverse events regardless of attribution are reported here.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 4/20 • up to one year All adverse events regardless of attribution are reported here.
Psychiatric disorders Mood alteration: Depression	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Skin and subcutaneous tissue disorders Rash/desquamation	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Diarrhea	20.0% 4/20 • up to one year All adverse events regardless of attribution are reported here.
Nervous system disorders Dizziness	30.0% 6/20 • up to one year All adverse events regardless of attribution are reported here.
Skin and subcutaneous tissue disorders Dry skin	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Enteritis (inflammation of the small bowel)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
General disorders Fatigue (asthenia, lethargy, malaise)	40.0% 8/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Flatulence	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Fracture	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Extremity-lower (gait/walking)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Pain: Intestine	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Blood and lymphatic system disorders Hemoglobin	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Nervous system disorders Pain: Head/headache	30.0% 6/20 • up to one year All adverse events regardless of attribution are reported here.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Cardiac disorders Hypertension	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Respiratory, thoracic and mediastinal disorders Flu-like syndrome	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Psychiatric disorders Insomnia	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Respiratory, thoracic and mediastinal disorders Edema, larynx	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Investigations Leukocytes (total WBC)	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Nervous system disorders Memory impairment	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Mucosa	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Nausea	25.0% 5/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Neck	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Nervous system disorders Pain: Neuralgia/peripheral nerve	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Extremity-limb	70.0% 14/20 • up to one year All adverse events regardless of attribution are reported here.
Reproductive system and breast disorders Pain: Pelvis	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Nervous system disorders Neuropathy: motor	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Nervous system disorders Neuropathy: sensory	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Respiratory, thoracic and mediastinal disorders Pain: Throat/pharynx/larynx	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Skin and subcutaneous tissue disorders Photosensitivity	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Lung (pneumonia)	20.0% 4/20 • up to one year All adverse events regardless of attribution are reported here.
Skin and subcutaneous tissue disorders Pruritus/itching	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
General disorders Fever (in the absence of neutropenia)	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
General disorders Rigors/chills	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Seroma	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Sinus	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Pain: Stomach	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic): Oral cavity	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Renal and urinary disorders Incontinence, urinary	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Renal and urinary disorders Urinary retention (including neurogenic bladder):	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Urinary tract NOS	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Reproductive system and breast disorders Vaginal discharge (non-infectious)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Eye disorders Vision-blurred vision	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Gastrointestinal disorders Vomiting	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
General disorders Weight loss	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain: Buttock	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Upper airway NOS	50.0% 10/20 • up to one year All adverse events regardless of attribution are reported here.
Cardiac disorders Left ventricular diastolic dysfunction	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Stomach	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Oral cavity-gums (gingivitis)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Immune system disorders Allergic reaction/ hypersensitivity	25.0% 5/20 • up to one year All adverse events regardless of attribution are reported here.
Cardiac disorders Cardiac General - Other: heart flutter	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection - Other: staph infection (skin)	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Metabolism and nutrition disorders Metabolic/Laboratory - Other: elevated BUN	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Eye disorders Dry Eyes	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
General disorders Pain NOS	15.0% 3/20 • up to one year All adverse events regardless of attribution are reported here.
Respiratory, thoracic and mediastinal disorders Nasal Cavity/Paranasal Sinus Reactions	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Reproductive system and breast disorders Erectile Dysfunction	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with unknown ANC: Sinus	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection with unknown ANC: Vagina	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
General disorders Edema: limb	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Lumbar spine-range of motion	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower	10.0% 2/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection, other: upper respiratory infection	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Infections and infestations Infection, other: abdominal infection	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Skin and subcutaneous tissue disorders Dermatology/skin, other: finger splinter	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Immune system disorders Allergy/Immunology, other: autoimmune disorder	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.
Musculoskeletal and connective tissue disorders Pain, other: hip	5.0% 1/20 • up to one year All adverse events regardless of attribution are reported here.

Additional Information

Amitabha Mazumder, MD

Perlmutter Cancer Center at NYU Langone

Phone: 212-731-5757

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place