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

December 10, 2012
July 17, 2014
February 2013
July 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01749969 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase 1 SAR650984 Combination With Lenalidomide
A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: SAR650984
    Pharmaceutical form:solution Route of administration: intravenous
  • Drug: Lenalidomide
    Pharmaceutical form:capsules Route of administration: oral
Experimental: Dose A
SAR650984 in combination with Lenalidomide
Interventions:
  • Drug: SAR650984
  • Drug: Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
39
July 2017
July 2017   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01749969
TCD11863, U1111-1119-3107
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP