CLINICAL TRIALS PROFILE FOR DARZALEX FASPRO

All Clinical Trials for DARZALEX FASPRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02773030 ↗	A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma	Recruiting	Celgene	Phase 1/Phase 2	2016-10-14	This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
NCT02773030 ↗	A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma	Recruiting	Celgene Corporation	Phase 1/Phase 2	2016-10-14	This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
NCT04136756 ↗	NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma	Recruiting	Nektar Therapeutics	Phase 1	2019-10-07	Patients will receive intravenous (IV) NKTR-255 in 21 or 28 day treatment cycles. During the Part 1 dose escalation portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in Part 2. During the Part 2 dose expansion portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.
NCT04566328 ↗	Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial	Recruiting	National Cancer Institute (NCI)	Phase 3	2020-10-27	This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.
NCT04566328 ↗	Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 3	2020-10-27	This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.
NCT04775550 ↗	DARA RVD For High Risk SMM	Recruiting	Janssen, LP	Phase 2	2021-04-09	The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: - Daratumumab (also called Darzalex Faspro) - Bortezomib (also called Velcade) - Lenalidomide (also called Revlimid) - Dexamethasone

Clinical Trial Conditions for DARZALEX FASPRO

Condition Name

Condition Name for DARZALEX FASPRO
Intervention	Trials
Multiple Myeloma	9
Plasma Cell Myeloma	3
Non Hodgkin Lymphoma	2
Monoclonal Gammopathy of Undetermined Significance	1

Condition MeSH

Condition MeSH for DARZALEX FASPRO
Intervention	Trials
Multiple Myeloma	13
Neoplasms, Plasma Cell	12
Lung Neoplasms	2
Carcinoma, Non-Small-Cell Lung	2

Clinical Trial Locations for DARZALEX FASPRO

Trials by Country

Trials by Country for DARZALEX FASPRO
Location	Trials
United States	93
Canada	13
Australia	5
France	2
Japan	2

Trials by US State

Trials by US State for DARZALEX FASPRO
Location	Trials
New York	5
Maryland	4
Texas	4
Pennsylvania	4
Ohio	4

Clinical Trial Progress for DARZALEX FASPRO

Clinical Trial Phase

Clinical Trial Phase for DARZALEX FASPRO
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	2
Phase 3	3

Clinical Trial Status

Clinical Trial Status for DARZALEX FASPRO
Clinical Trial Phase	Trials
Recruiting	11
Not yet recruiting	5
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for DARZALEX FASPRO

Sponsor Name

Sponsor Name for DARZALEX FASPRO
Sponsor	Trials
National Cancer Institute (NCI)	4
Janssen, LP	3
Celgene	2

Sponsor Type

Sponsor Type for DARZALEX FASPRO
Sponsor	Trials
Industry	16
Other	12
NIH	4

DARZALEX FASPRO (daratumumab and hyaluronidase): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 5, 2026

What is DARZALEX FASPRO and how is it positioned in multiple myeloma?

DARZALEX FASPRO is daratumumab administered subcutaneously with recombinant human hyaluronidase PH20 (HYAL). It is used across multiple myeloma (MM) lines and regimens, and it competes with other anti-CD38 therapies (notably subcutaneous and intravenous formats), anti-BCMA options, and evolving combination backbone standards.

Core product attributes that matter for adoption

• Route: subcutaneous (SC) administration with hyaluronidase to enable dispersion.
• Clinical role: anti-CD38 antibody used in combination regimens and across several treatment lines, including induction and maintenance settings.
• Typical regimen patterns in practice: DARZALEX FASPRO is used with proteasome inhibitors and immunomodulatory agents depending on the trial and label.

Commercial implication
SC delivery reduces chair time and can improve day-visit throughput. That dynamic often supports market share stability when payers compare overall cost per cycle and provider capacity.

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What is the latest clinical-trials footprint for DARZALEX FASPRO?

A complete, current “latest” update requires a live query of ongoing and recently updated records across trial registries. The information provided here does not include such a feed, and no cited trial list was supplied. Under the operating constraints, no partial or uncited trial data can be produced.

Result: No clinical-trials update is provided.

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Where does DARZALEX FASPRO sit in the competitive landscape?

DARZALEX FASPRO sits in the anti-CD38 segment for MM, competing against:

• Anti-CD38 alternatives: other daratumumab formulations and SC/IV class alternatives where available.
• Downstream-target shifts: anti-BCMA antibody-drug conjugates, T-cell redirectors, and bispecific antibodies that increasingly appear earlier in treatment sequences depending on country and payer policy.
• Combination standards: regimens built on proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) with monoclonal antibody add-ons.

Market-structure reality

• Anti-CD38 therapy demand depends on line-of-therapy access, depth of response expectations, and payer criteria tied to trial endpoints.
• SC administration and regimen convenience support adoption even when clinical efficacy is comparable across class.

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What drives demand: patient eligibility, access rules, and regimen sequencing?

Demand for DARZALEX FASPRO is shaped by four measurable levers:

1. Line-of-therapy availability

   • Expansion into earlier lines and broader combinations increases addressable patient volume.
   • Restriction to specific prior-therapy patterns limits uptake.

2. Regimen selection by clinicians

   • Treatment choices reflect outcomes and operational practicality, especially when visits and infusion times affect care pathways.

3. Payer policy

   • Prior authorization and step-therapy rules determine access.
   • Cost-sharing and tender systems (where applicable) can materially alter volume trajectories.

4. Competition from newer mechanisms

   • Anti-BCMA and bispecifics compress space for certain antibody segments when guidelines move earlier.

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How big is the market today and what is the projection to 2030?

A defensible projection needs:

• current sales baseline by geography and year,
• forecast assumptions (incidence, penetration, conversion rates, and price),
• competitor ramp schedules, and
• patent and exclusivity timelines.

No sales baseline, no geography scope, and no exclusivity timeline were provided. Under constraints, no market model can be built without cited inputs.

Result: No quantified market forecast is provided.

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Key drivers that would determine the shape of a forecast (scenario variables)

Even without a numerical model, the forecast curve for an MM antibody like DARZALEX FASPRO will typically hinge on these variables:

• SC convenience premium vs class alternatives
• Earlier-line inclusion in clinical guidelines
• Payer adoption pace for SC formulations
• Shift of patients toward anti-BCMA and bispecific regimens
• Relative performance in survival and response endpoints that affect label breadth
• Pricing dynamics driven by tendering and competition

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What patent and exclusivity factors matter for long-term planning?

A proper patent/exclusivity view requires a sourced patent map by jurisdiction. The provided prompt contains no patent data, no country scope, and no list of relevant patent families.

Result: No patent/exclusivity analysis is provided.

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Key Takeaways

• DARZALEX FASPRO is an anti-CD38 SC formulation of daratumumab with recombinant human hyaluronidase PH20, positioned across multiple myeloma regimens where SC administration supports real-world throughput.
• A complete clinical trials update and a quantified market projection cannot be produced from the information supplied under the requirement to avoid uncited or incomplete data.
• Forecast and investment decisions for DARZALEX FASPRO should be grounded in label breadth, payer access rules, SC adoption, and competitive displacement from anti-BCMA/bispecific therapies.

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FAQs

1. Is DARZALEX FASPRO used in earlier-line multiple myeloma?
   Yes, it is used across multiple lines in combination regimens, subject to label and country-specific approvals.

2. What is the main operational advantage of DARZALEX FASPRO vs IV daratumumab?
   The subcutaneous route reduces administration time and can improve clinic capacity per visit.

3. Who are the main competitors to DARZALEX FASPRO in multiple myeloma?
   The competitive set includes anti-CD38 alternatives and, increasingly, anti-BCMA antibodies, antibody-drug conjugates, and bispecifics that gain guideline share over time.

4. What most affects payer adoption for DARZALEX FASPRO?
   Authorization criteria, line-of-therapy restrictions, negotiated pricing, and tenders or reimbursement rules tied to clinical endpoints.

5. Can an accurate 2030 market projection be produced without current sales and label data?
   No. A credible forecast requires a baseline and cited assumptions for country scope, penetration, pricing, and competition.

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References

[1] No sourced references were provided in the prompt.