Phase 1 SAR650984 Combination With Lenalidomide (LenCombo)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01749969
First received: December 10, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

Primary Objective:

To determine the maximum tolerated dose of SAR650984 with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.

Secondary Objectives:

To evaluate the safety, including immunogenicity, of SAR650984 in combination with lenalidomide in relapse or refractory multple myeloma. The severity, frequency and incidence of all toxicities will be assessed.

To evaluate the pharmacokinetics (PK) of SAR650984 when administered in combination with lenalidomide and the PK of lenalidomide in combination with SAR650984 and dexamethasone.

To assess the relationship between clinical (adverse event and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results.

Estimate the activity (response rate) using International Myeloma Working Group defined response criteria of SAR650984 plus lenalidomide and low dose dexamethasone.

To describe overall survival, progression free survival (PFS) and time to disease progression in patients treated with this combination.


Condition Intervention Phase
Multiple Myeloma
Drug: SAR650984
Drug: Lenalidomide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with adverse events when treated with SAR650984 in combination with Lenalidomide [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary assessment of partial response [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Preliminary assessment of complete response [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Preliminary assessment of progression free survival [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Preliminary assessment of survival [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - area under curve (AUC) [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - maximum concentration (Cmax) [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - plasma half-life (T 1/2) [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Number of CD38 receptors occupied by SAR650984 [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Number of anti-SAR antibodies in response to SAR650984 [ Time Frame: Up to one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: February 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose A
SAR650984 in combination with Lenalidomide
Drug: SAR650984
Pharmaceutical form:solution Route of administration: intravenous
Drug: Lenalidomide
Pharmaceutical form:capsules Route of administration: oral

Detailed Description:

The study duration for an individual patient will include a screening period for inclusion of up to 21 days, and at least 4 weeks of treatment in the absence of severe adverse reaction, dose limiting toxicity or disease progression plus up to 60 days post-treatment follow up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patients age 18 years or older.
  • Diagnosis of multiple myeloma & documentation of at least 2 prior therapies (induction therapy is considered one prior therapy); there is no maximum number of prior regimens & prior bone marrow transplant is acceptable.
  • Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior therapy.
  • Patients may have received prior immunomodulatory drugs (IMiDs) (eg, lenalidomide or thalidomide).
  • Patients with measurable disease.
  • Patients with a Karnofsky ≥60% performance status.
  • Females of childbearing potential (FCBP).
  • Voluntary written informed consent before performance of any study-related procedure not part of routine medical care with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Ability to understand the purpose and risks of the study & provide signed & dated informed consent & authorization to use protected health information (in accordance with national & local subject privacy regulations).
  • Able to take aspirin daily as prophylactic anti-coagulation therapy (patients intolerant to aspirin may use warfarin, low molecular weight heparin or equivalent anti-platelet therapy).
  • Adequate organ function.

Exclusion criteria:

  • Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
  • Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, & immunotherapy) within 21 days except for alkylating agents (eg, melphalan) where 28 days will be required or participated in another clinical trial during the past 30 days.
  • History of significant cardiovascular disease within the past 6 months, unless the disease is well-controlled.
  • Prior peripheral stem cell transplant within 12 weeks of the first dose of study treatment.
  • Daily requirement for corticosteroids (>10 mg/kg prednisone qd) (except for inhalation corticosteroids).
  • Evidence of mucosal or internal bleeding.
  • Prior radiation therapy or major surgical procedure within 4 weeks of the first dose of study treatment.
  • Known active infection requiring parenteral or oral anti-infective treatment.
  • Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
  • Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.
  • Hypersensitivity to any of the components of study therapy that is not amenable to premedication with steroids and H2 blockers.
  • Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.
  • Neuropathy ≥ Grade 3 or painful neuropathy ≥ Grade 2.
  • Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation, active peptic ulcer or prior surgical procedures or bowel resection affecting absorption.
  • Pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749969

Locations
United States, California
Investigational Site Number 840004
San Francisco, California, United States, 94117
United States, Florida
Investigational Site Number 840001
Tampa, Florida, United States, 33612
United States, Missouri
Investigational Site Number 840002
St Louis, Missouri, United States, 63110
United States, New York
Investigational Site Number 840005
New York, New York, United States, 10021
United States, Ohio
Investigational Site Number 840003
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01749969     History of Changes
Other Study ID Numbers: TCD11863, U1111-1119-3107
Study First Received: December 10, 2012
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014