Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma

Browse trials for

• Multiple Myeloma 3,632
• Neoplasms, Plasma Cell 2,306

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 64 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Study arms

• Experimental
  Arm I

  Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.

  Drug: carfilzomib · Drug: cyclophosphamide · Drug: thalidomide · Drug: dexamethasone

Interventions

• Drugcarfilzomib

  Given IV

  Also known as: PR-171

• Drugcyclophosphamide

  Given orally

  Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana, Enduxan

• Drugthalidomide

  Given orally

  Also known as: alpha-phthalimidoglutarimide, Contergan, Kevadon, Synovir, THAL, Thalomid

• Drugdexamethasone

  Given orally

  Also known as: Aeroseb-Dex, Decaderm, Decadron, Decaspray, DM, DXM

Primary outcomes

1. Maximum Tolerated Dose (Phase I)

   To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs

   Time frame: From baseline to end of active treatment, up to 12 28-day cycles.

2. Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)

   The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients. A complete response is defined as: * Negative immunofixation of the serum and urine * If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio * \< 5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytomas A very good partial response is defined as: * Serum and urine M-component detectable by immunofixation but not on electrophoresis or * If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent * Urine M-component \<100 mg per 24 hour

   Time frame: Following the first 4 cycles of treatment (28 day cycles)

Secondary outcomes

1. Progression-free Survival (Phase II)

   PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: • Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas • Development of hypercalcemia (corrected serum calcium \>11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder

   Time frame: From baseline to progression or death up to 3 years

2. Time to Treatment Failure

   The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier

   Time frame: From baseline to end of active treatment

3. Stem Cell Collection and Engraftment (Phase II)

   For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.

   Time frame: Following the first 4 courses of treatment

4. Complete Response (Phase II)

   In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.

   Time frame: Following the first 4 courses of treatment

5. Survival Time (Phase II)

   Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier

   Time frame: From baseline to death

6. Progression Free Survival (12 Month)

   Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.

   Time frame: 12 months

7. Progession Free Survival (24 Month)

   Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.

   Time frame: 24 months

8. Overall Survival (12 Month)

   12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.

   Time frame: From baseline to death

9. Overall Survival (24 Month)

   24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.

   Time frame: From baseline to death

Baseline characteristics