Know Cancer

forgot password

Phase I Dose Finding Study Assessing Safety and Tolerability of SST0001 in Advanced Multiple Myeloma.

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

Phase I Dose Finding Study Assessing Safety and Tolerability of SST0001 in Advanced Multiple Myeloma.

Multicenter, open label, uncontrolled Phase I First In Man trial in advanced refractory
multiple myeloma, to determine the Maximum Tolerated Dose (MTD) of SST0001 given
subcutaneously (sc) once daily for 5 or 10 days, in a cycle of 28 days. A starting dose of
25 mg (flat dose) is given once daily for 5 days (from Day 1 to Day 5). In the subsequent
cohort 25 mg are administered once daily for 10 days (from Day 1 to 5 and from Day 8 to 12).
Dose escalation with SST0001 administered for 10 days is performed in subsequent cohorts,
depending on toxicities observed.

Indirect pharmacokinetics based on Activated Partial Thromboplastin Time (aPTT)
modifications in all patients (minimum of 3 patients in each cohort) during the first cycle
of treatment.

Pharmacodynamics in all patients during the first cycle of treatment, based on modifications
of coagulation parameters.

During the study any hints of anti-tumor activity will also be evaluated based on use of
surrogate parameters (monoclonal serum and urine protein modifications).

Inclusion Criteria:

- Advanced, heavily pretreated refractory multiple myeloma (MM).

- Patient should have exhausted all available anti MM therapies.

- Age ≥18 years.

- ECOG (Eastern Cooperative Oncology Group)performance status ≤ 2.

- Life expectancy of more than 3 months.

- No concomitant use of anticoagulants or antiplatelets drugs such as aspirin, NSAIDs
(Nonsteroidal Antiinflammatory Drug), Clopidogrel, Unfractionated Heparin, Low
Molecular Weight Heparin (e.g. Enoxaparin), Fondaparinux, Dabigatran, Rivaroxaban,
Apixaban and Warfarin.

- No platelets diseases or allergy to anticoagulants.

- WBC (White Blood Cell) ≥2000/µL; Platelets ≥100,000/µL; Hb ≥ 8 g/dL.

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST (aspartate
aminotransferase)and ALT (alanine aminotransferase)≤ 3 x the ULN; serum creatinine ≤
1.5 x the ULN (Upper Limit of Normal).

- aPTT, TT, INR, fibrinogen, D-dimer within ULN.

- Disease free of prior malignancies for ≥ 3 years.

- No acute gastrointestinal bleeding or any major bleeding (e.g CNS) in the past 2
years or any significant bleeding history.

- No known central nervous system involvement by myeloma.

- Capacity of understanding the nature of the trial and giving written informed

- Unless a female patient is post-menopausal or surgically sterilized, must be willing
to use an acceptable method of birth control (hormonal contraceptive, intrauterine
device, barrier contraceptive with spermicide, or abstinence) for the duration of the

- Male patient must agree to use an acceptable method for contraception (barrier
contraceptive or abstinence) for the duration of the study.

Exclusion Criteria:

- Pregnancy or lactation or unwillingness to use adequate method of birth control

- Ascertained or presumptive hypersensitivity to the active principle and/or
formulations ingredients.

- Active uncontrolled viral, bacterial, or fungal infection or history of HIV,
hepatitis B or C, or any infection requiring systemic antivirals or antimicrobials.

- Grade ≥ 2 toxicity due to previous anti-neoplastic therapy (except alopecia), and
Grade ≥ 3 peripheral motor or sensory neuropathy, in the 2 weeks before treatment
(CTCAE V4.0).

- Less than 2 weeks since most recent chemotherapy, or concurrent chemotherapy.

- Presence of cirrhosis or chronic hepatitis.

- Diagnosis of amyloidosis or diagnosis of plasma cell leukaemia.

- Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial
infarction within one year prior to study entry, uncontrolled hypertension or
arrhythmia), neurological or psychiatric disorder.

- Presence of uncontrolled intercurrent illness or any condition which in the judgement
of the investigator would place the subject at undue risk or interfere with the
results of the study.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD).

Outcome Description:

Maximum tolerated dose (MTD) (based upon first cycle study drug related dose limiting toxicities [DLTs]) of SST0001 given subcutaneously over repeated administration during each treatment cycle. MTD definition: ≥ 2/6 patients with a DLT at the first cycle (28 days).

Outcome Time Frame:

28 days of first cycle of therapy.

Safety Issue:


Principal Investigator

Alessandro Rambaldi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy


Italy: National Institute of Health

Study ID:




Start Date:

November 2012

Completion Date:

February 2015

Related Keywords:

  • Multiple Myeloma
  • Heparanase inhibitor
  • Multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell