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Trial record 1 of 1 for:    TCD14079
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SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients (PomdeSAR)

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ClinicalTrials.gov Identifier: NCT02283775
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objectives:

Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM).

Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR).

Secondary Objectives:

  • To evaluate the infusion duration (Part B).
  • To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B).
  • To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B).
  • To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A).
  • To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B).
  • To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density at baseline (Part A).

Condition or disease Intervention/treatment Phase
Plasma Cell Myeloma Drug: Isatuximab SAR650984 Drug: Pomalidomide Drug: Dexamethasone Phase 1

Detailed Description:
The study duration for an individual patient will include a screening period for inclusion of up to 21 days. The treatment period may continue until disease progression, unacceptable adverse reaction, or other reason for discontinuation. After study treatment discontinuation an end of treatment (EOT) visit will be done at approximately 30 days after last study treatment component administration to assess safety. If the last ADA sample is positive or inconclusive, additional ADA will be sampled 3 months later. No further ADA will be sampled, even if this 3-month sample is positive. Patients who discontinue treatment for reasons other than progression of disease will be followed every month until progression or initiation of subsequent therapy, for a maximum of one year, whichever comes first.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of SAR650984 (Isatuximab) in Combination With Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : May 15, 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: PomdeSAR

Part A: Isatuximab (escalating dose) on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression

Part B: Isatuximab 10 mg/kg on Day 1, 8, 15, and 22, then Day 1 and 15 + pomalidomide 4 mg on Day 1 to 21 + dexamethasone 40 mg (20 mg in patients of 75 years or older) on Day 1, 8, 15, 22 in 28-day cycles up to disease progression

Drug: Isatuximab SAR650984
Pharmaceutical form:solution for infusion Route of administration: intravenous

Drug: Pomalidomide
Pharmaceutical form:capsules Route of administration: oral
Other Name: Pomalyst

Drug: Dexamethasone
Pharmaceutical form:tablets or solution for infusion Route of administration: oral or intravenous




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) [ Time Frame: Part A: Up to 4 weeks ]
  2. Number of patients with adverse events and clinically significant changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grade scaling [ Time Frame: Part A: Up to 30 days for patients experiencing progressive disease and up to one year or the initiation of a new line of treatment for patients leaving the study for reasons other than progressive disease ]
  3. Incidence of grade ≥3 IARs according to the NCI-CTC version 4.03 grade scaling [ Time Frame: Part B: Up to 8 weeks ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months ]
  2. Pharmacokinetics: Partial area under the serum concentration time curve (AUC) [ Time Frame: Part A: Up to approximately 10 months ]
  3. Pharmacokinetics: maximum observed concentration (Cmax) [ Time Frame: Part A: Up to approximately 10 months ]
  4. Immune response: levels of human anti-human antibodies (ADA) [ Time Frame: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months ]
  5. Duration of response - Time [ Time Frame: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months ]
  6. Clinical Benefit rate [ Time Frame: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months ]
  7. Infusion duration [ Time Frame: Part B: Up to approximately 10 months ]
  8. Safety of isatuximab administration from fixed volume [ Time Frame: Part B: Up to 30 days for patients experiencing progressive disease and up to one year or the initiation of a new line of treatment for patients leaving the study for reasons other than progressive disease ]
  9. Relationship between clinical effect and CD38 receptor density [ Time Frame: Part A: Up to approximately 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patient has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria.
  • Patient had received at least two previous therapies including lenalidomide and proteasome inhibitor and have demonstrated disease progression on therapy or after completion of the last therapy.
  • Patients with measurable disease defined as at least one of the following:

    • Serum M protein ≥0.5 g/dL (≥5 g/L);
    • Urine M protein ≥200 mg/24 hours;
    • Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • Poor bone marrow reserve.
  • Poor organ function.
  • Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol, sucrose, histidine or polysorbate 80.
  • Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the Investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results.
  • Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283775


Locations
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United States, Arizona
Investigational Site Number 840001
Scottsdale, Arizona, United States, 85054
United States, California
Investigational Site Number 840006
Duarte, California, United States, 91010
United States, Connecticut
Investigational Site Number 840018
New Haven, Connecticut, United States, 06520-8017
United States, Illinois
Investigational Site Number 840011
Decatur, Illinois, United States, 62526
United States, Massachusetts
Investigational Site Number 840004
Boston, Massachusetts, United States, 02115
Investigational Site Number 840104
Boston, Massachusetts, United States, 2114
United States, North Carolina
Investigational Site Number 840010
Chapel Hill, North Carolina, United States, 27599
Investigational Site Number 840003
Charlotte, North Carolina, United States, 28204
United States, Ohio
Investigational Site Number 840014
Canton, Ohio, United States, 44718
United States, South Carolina
Investigational Site Number 840016
Charleston, South Carolina, United States, 29425
United States, Utah
Investigational Site Number 840015
Salt Lake City, Utah, United States, 84112-5550
United States, Washington
Investigational Site Number 840005
Seattle, Washington, United States, 98108
United States, Wisconsin
Investigational Site Number 840017
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02283775     History of Changes
Other Study ID Numbers: TCD14079
U1111-1155-7484 ( Other Identifier: UTN )
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents