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A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

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.

Inclusion 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

- 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not part of routine medical care with the understanding that consent may be withdrawn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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Number of patients with adverse events when treated with SAR650984 in combination with Lenalidomide

Outcome Time Frame:

Up to one year

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

November 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Investigational Site Number 840004 Santa Monica, California  90403
Investigational Site Number 840001 Port St. Lucie, Florida  34952
Investigational Site Number 840003 Middletown, Ohio  45042
Investigational Site Number 840002 St Louis, Missouri  63110
Investigational Site Number 840005 New York, New York  10065