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Plasma Cell MyelomaPhase 1PomdeSARNCT02283775

SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

A Phase 1 study testing Isatuximab SAR650984, Pomalidomide and Dexamethasone in people with Plasma Cell Myeloma, run by Sanofi at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasma Cell Myeloma
What is being tested?
Isatuximab SAR650984, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
13 sitesUnited States
Study dates
15 May 2015to 26 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Investigational Site Number 840004

    Boston, Massachusetts, 02115

  • Investigational Site Number 840104

    Boston, Massachusetts, 2114

  • Investigational Site Number 840014

    Canton, Ohio, 44718

  • Investigational Site Number 840010

    Chapel Hill, North Carolina, 27599

  • Investigational Site Number 840016

    Charleston, South Carolina, 29425

  • Investigational Site Number 840003

    Charlotte, North Carolina, 28204

  • Investigational Site Number 840011

    Decatur, Illinois, 62526

  • Investigational Site Number 840006

    Duarte, California, 91010

  • Investigational Site Number 840017

    Milwaukee, Wisconsin, 53226

  • Investigational Site Number 840018

    New Haven, Connecticut, 06520-8017

  • Investigational Site Number 840015

    Salt Lake City, Utah, 84112-5550

  • Investigational Site Number 840001

    Scottsdale, Arizona, 85054

  • Investigational Site Number 840005

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: A Phase 1b Study of SAR650984 (Isatuximab) in Combination With Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma

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).

Read more

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).
Read the 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.

Being tested
Isatuximab SAR650984, Pomalidomide, Dexamethasone
Keywords
Anti-CD38 monoclonal antibody
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isatuximab SAR650984Drug

    Also called Sarclisa

    Pharmaceutical form:solution for infusion Route of administration: intravenous

  • PomalidomideDrug

    Also called Pomalyst

    Pharmaceutical form:capsules Route of administration: oral

  • DexamethasoneDrug

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

Study groups in NCT02283775
Study groupRoleWhat they receive
PomdeSARExperimentalPart 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
Receives: Drug: Isatuximab SAR650984; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLTs)

    Measured: 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

    Measured: 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

    Measured: Part B: Up to 8 weeks

Secondary outcomes (9)

  1. Overall response rate

    Measured: 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)

    Measured: Part A: Up to approximately 10 months

  3. Pharmacokinetics: maximum observed concentration (Cmax)

    Measured: Part A: Up to approximately 10 months

  4. Immune response: levels of human anti-human antibodies (ADA)

    Measured: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months

  5. Duration of response - Time

    Measured: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months

  6. Clinical Benefit rate

    Measured: Part A: Up to approximately 8 months; Part B: Up to approximately 10 months

  7. Infusion duration

    Measured: Part B: Up to approximately 10 months

  8. Safety of isatuximab administration from fixed volume

    Measured: 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

    Measured: Part A: Up to approximately 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study start15 May 2015
  3. Primary completion26 May 2021
  4. Study completion26 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283775
Sponsor's protocol ID
TCD14079
Other IDs
U1111-1155-7484
Acronym
PomdeSAR
Status last verified
Jul 2021
First submitted
3 Nov 2014
Last updated
9 Jul 2021
Results posted
No
Data monitoring committee
No

Publications

  • Usmani SZ, Karanes C, Bensinger WI, D'Souza A, Raje N, Tuchman SA, Sborov D, Laubach JP, Bianchi G, Kanagavel D, Saleem R, Dubin F, Campana F, Richardson PG. Final results of a phase 1b study of isatuximab short-duration fixed-volume infusion combination therapy for relapsed/refractory multiple myeloma. Leukemia. 2021 Dec;35(12):3526-3533. doi: 10.1038/s41375-021-01262-w. Epub 2021 May 28.

    PubMed 34050260

  • Mikhael J, Belhadj-Merzoug K, Hulin C, Vincent L, Moreau P, Gasparetto C, Pour L, Spicka I, Vij R, Zonder J, Atanackovic D, Gabrail N, Martin TG, Perrot A, Bensfia S, Weng Q, Brillac C, Semiond D, Mace S, Corzo KP, Leleu X. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab. Blood Cancer J. 2021 May 12;11(5):89. doi: 10.1038/s41408-021-00478-4. No abstract available.

    PubMed 33980831

  • Mikhael J, Richardson P, Usmani SZ, Raje N, Bensinger W, Karanes C, Campana F, Kanagavel D, Dubin F, Liu Q, Semiond D, Anderson K. A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019 Jul 11;134(2):123-133. doi: 10.1182/blood-2019-02-895193. Epub 2019 Mar 12.

    PubMed 30862646

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Isatuximab SAR650984, Pomalidomide and Dexamethasone in people with Plasma Cell Myeloma, run by Sanofi at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) (time frame: Part A: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283775, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.

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